Trial Outcomes & Findings for Prehospital Tranexamic Acid Use for Traumatic Brain Injury (NCT NCT01990768)

NCT ID: NCT01990768

Last Updated: 2019-01-14

Results Overview

GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

967 participants

Primary outcome timeframe

6 months post-injury

Results posted on

2019-01-14

Participant Flow

Between May 2015 and March 2017, participants were enrolled by 39 emergency management service (EMS) agencies and transported to 20 trauma centers within 12 regional sites in North America.

Some persons for whom the blinded study kit was opened did not actually receive any of the study drug. These persons are not included in the enrollment numbers. However, they are enumerated in the first section of the patient flow tables.

Participant milestones

Participant milestones
Measure	Placebo Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
Intervention Started STARTED	345	345	373
Intervention Started COMPLETED	309	312	346
Intervention Started NOT COMPLETED	36	33	27
Prehospital Study Drug Infusion STARTED	309	312	346
Prehospital Study Drug Infusion COMPLETED	290	285	327
Prehospital Study Drug Infusion NOT COMPLETED	19	27	19
In-Hospital Study Drug Infusion STARTED	309	312	346
In-Hospital Study Drug Infusion COMPLETED	214	229	266
In-Hospital Study Drug Infusion NOT COMPLETED	95	83	80
6-Month Follow-up STARTED	309	312	346
6-Month Follow-up COMPLETED	270	261	288
6-Month Follow-up NOT COMPLETED	39	51	58

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
Intervention Started Found to be ineligible	14	13	11
Intervention Started Study drug issue or kit malfunction	9	6	7
Intervention Started Patient became ineligible due to vitals	5	5	2
Intervention Started Not enough time for EMS to enroll	4	3	0
Intervention Started Patient care priority	1	2	3
Intervention Started IV lost	2	2	2
Intervention Started Required CPR	1	1	0
Intervention Started Seizure or hx of seizure	0	0	2
Intervention Started Discovered to be pregnant	0	1	0
Prehospital Study Drug Infusion Protocol non-compliance	4	11	10
Prehospital Study Drug Infusion Seizure or concern for seizure	4	3	4
Prehospital Study Drug Infusion Required CPR	2	6	0
Prehospital Study Drug Infusion Other safety concern	2	1	1
Prehospital Study Drug Infusion Death	3	1	1
Prehospital Study Drug Infusion Discharged	2	1	0
Prehospital Study Drug Infusion Withdrawal by Subject	1	0	0
Prehospital Study Drug Infusion Emergency unblinding	0	0	1
Prehospital Study Drug Infusion Unknown if completed	1	4	2
In-Hospital Study Drug Infusion Discharged	19	18	13
In-Hospital Study Drug Infusion Protocol non-compliance	14	17	10
In-Hospital Study Drug Infusion Withdrawal by Subject	13	7	12
In-Hospital Study Drug Infusion Death or comfort care	12	11	6
In-Hospital Study Drug Infusion Emergency unblinding	11	4	7
In-Hospital Study Drug Infusion Seizure or concern for seizure	8	9	17
In-Hospital Study Drug Infusion CVA/thrombotic event or concern for one	5	5	4
In-Hospital Study Drug Infusion Required CPR	3	7	1
In-Hospital Study Drug Infusion Other safety concern	4	2	3
In-Hospital Study Drug Infusion Taken into police custody	4	0	3
In-Hospital Study Drug Infusion Found not to be injured	1	1	1
In-Hospital Study Drug Infusion Transfer to non-participating facility	1	1	0
In-Hospital Study Drug Infusion Other procoagulant administered	0	1	2
In-Hospital Study Drug Infusion Unknown if completed	0	0	1
6-Month Follow-up Withdrawal by Subject	25	25	26
6-Month Follow-up Calls unreturned or refused contact	4	15	20
6-Month Follow-up No contact information	5	6	5
6-Month Follow-up Homeless	4	3	6
6-Month Follow-up Prisoner at time of enrollment	0	0	1
6-Month Follow-up Prisoner at time of follow-up	0	2	0
6-Month Follow-up Patient at psychiatric hospital	1	0	0

Baseline Characteristics

Cause of injury missing on 1 placebo participant and 5 bolus only participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=309 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=312 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=345 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Total n=966 Participants Total of all reporting groups
Age, Continuous	36 years n=309 Participants	39 years n=312 Participants	40 years n=345 Participants	38 years n=966 Participants
Sex: Female, Male Female	76 Participants n=309 Participants	85 Participants n=312 Participants	90 Participants n=345 Participants	251 Participants n=966 Participants
Sex: Female, Male Male	233 Participants n=309 Participants	227 Participants n=312 Participants	255 Participants n=345 Participants	715 Participants n=966 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=309 Participants	40 Participants n=312 Participants	43 Participants n=345 Participants	123 Participants n=966 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	225 Participants n=309 Participants	224 Participants n=312 Participants	251 Participants n=345 Participants	700 Participants n=966 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	44 Participants n=309 Participants	48 Participants n=312 Participants	51 Participants n=345 Participants	143 Participants n=966 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=309 Participants	4 Participants n=312 Participants	4 Participants n=345 Participants	10 Participants n=966 Participants
Race (NIH/OMB) Asian	7 Participants n=309 Participants	13 Participants n=312 Participants	10 Participants n=345 Participants	30 Participants n=966 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=309 Participants	1 Participants n=312 Participants	1 Participants n=345 Participants	3 Participants n=966 Participants
Race (NIH/OMB) Black or African American	46 Participants n=309 Participants	50 Participants n=312 Participants	53 Participants n=345 Participants	149 Participants n=966 Participants
Race (NIH/OMB) White	213 Participants n=309 Participants	202 Participants n=312 Participants	227 Participants n=345 Participants	642 Participants n=966 Participants
Race (NIH/OMB) More than one race	2 Participants n=309 Participants	3 Participants n=312 Participants	0 Participants n=345 Participants	5 Participants n=966 Participants
Race (NIH/OMB) Unknown or Not Reported	38 Participants n=309 Participants	39 Participants n=312 Participants	50 Participants n=345 Participants	127 Participants n=966 Participants
Region of Enrollment Canada	24 participants n=309 Participants	28 participants n=312 Participants	36 participants n=345 Participants	88 participants n=966 Participants
Region of Enrollment United States	285 participants n=309 Participants	284 participants n=312 Participants	309 participants n=345 Participants	878 participants n=966 Participants
Penetrating injury	16 Participants n=309 Participants	12 Participants n=312 Participants	5 Participants n=345 Participants	33 Participants n=966 Participants
Cause of injury Motor vehicle occupant	113 Participants n=308 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	103 Participants n=312 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	115 Participants n=340 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	331 Participants n=960 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.
Cause of injury Motor vehicle motorcycle	33 Participants n=308 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	32 Participants n=312 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	44 Participants n=340 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	109 Participants n=960 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.
Cause of injury Motor vehicle bicycle/pedestrian	56 Participants n=308 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	61 Participants n=312 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	62 Participants n=340 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	179 Participants n=960 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.
Cause of injury Fall at ground level	37 Participants n=308 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	44 Participants n=312 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	45 Participants n=340 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	126 Participants n=960 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.
Cause of injury Fall at more than 1 meter	32 Participants n=308 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	40 Participants n=312 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	38 Participants n=340 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	110 Participants n=960 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.
Cause of injury Assault	24 Participants n=308 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	20 Participants n=312 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	25 Participants n=340 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	69 Participants n=960 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.
Cause of injury Suicide	9 Participants n=308 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	8 Participants n=312 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	5 Participants n=340 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	22 Participants n=960 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.
Cause of injury Other	4 Participants n=308 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	4 Participants n=312 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	6 Participants n=340 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.	14 Participants n=960 Participants • Cause of injury missing on 1 placebo participant and 5 bolus only participants.
Prehospital Glasgow Coma Scale 3-8	186 Participants n=309 Participants	169 Participants n=312 Participants	177 Participants n=345 Participants	532 Participants n=966 Participants
Prehospital Glasgow Coma Scale 9-12	115 Participants n=309 Participants	129 Participants n=312 Participants	159 Participants n=345 Participants	403 Participants n=966 Participants
Prehospital Glasgow Coma Scale 13-15	8 Participants n=309 Participants	14 Participants n=312 Participants	9 Participants n=345 Participants	31 Participants n=966 Participants
Injury Severity Score (ISS)	17 score on a scale n=302 Participants • ISS is sometimes not available if the patient dies early or there is insufficient information about injuries in specific body regions. The measure is missing for 7 placebo, 8 bolus-maintenance, and 3 bolus only participants.	17 score on a scale n=304 Participants • ISS is sometimes not available if the patient dies early or there is insufficient information about injuries in specific body regions. The measure is missing for 7 placebo, 8 bolus-maintenance, and 3 bolus only participants.	17 score on a scale n=342 Participants • ISS is sometimes not available if the patient dies early or there is insufficient information about injuries in specific body regions. The measure is missing for 7 placebo, 8 bolus-maintenance, and 3 bolus only participants.	17 score on a scale n=948 Participants • ISS is sometimes not available if the patient dies early or there is insufficient information about injuries in specific body regions. The measure is missing for 7 placebo, 8 bolus-maintenance, and 3 bolus only participants.
Head Abbreviated Injury Score (AIS) 0-1	76 Participants n=301 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	86 Participants n=306 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	103 Participants n=344 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	265 Participants n=951 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.
Head Abbreviated Injury Score (AIS) 2	46 Participants n=301 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	48 Participants n=306 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	48 Participants n=344 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	142 Participants n=951 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.
Head Abbreviated Injury Score (AIS) 3	61 Participants n=301 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	64 Participants n=306 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	66 Participants n=344 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	191 Participants n=951 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.
Head Abbreviated Injury Score (AIS) 4	67 Participants n=301 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	56 Participants n=306 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	71 Participants n=344 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	194 Participants n=951 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.
Head Abbreviated Injury Score (AIS) 5-6	51 Participants n=301 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	52 Participants n=306 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	56 Participants n=344 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.	159 Participants n=951 Participants • Head AIS is sometimes not available if the patient dies early or there is insufficient information about injuries to the head. The measure is missing for 8 placebo, 6 bolus-maintenance, and 1 bolus only participants.

PRIMARY outcome

Timeframe: 6 months post-injury

Population: Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.

Outcome measures

Outcome measures
Measure	Placebo n=309 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=312 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=345 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms n=657 Participants Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Dichotomized Glasgow Outcome Scale Extended (GOS-E) at 6 Months Unfavorable GOS-E (<=4)	107 Participants	108 Participants	110 Participants	218 Participants
Dichotomized Glasgow Outcome Scale Extended (GOS-E) at 6 Months Favorable GOS-E (>4)	163 Participants	153 Participants	178 Participants	331 Participants
Dichotomized Glasgow Outcome Scale Extended (GOS-E) at 6 Months Missing GOS-E	39 Participants	51 Participants	57 Participants	108 Participants

SECONDARY outcome

Timeframe: 28 days after hospital arrival

Population: Subjects for whom study drug administration was started and 28-day vital status was definitively obtained. Patients excluded from the counts include subjects who withdrew from the study prior to day 28 and subjects who were lost to follow-up.

The counts of patients who died on or before day 28 are reported.

Outcome measures

Outcome measures
Measure	Placebo n=285 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=285 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=318 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Number of Participants Who Died Within 28 Days	50 Participants	53 Participants	40 Participants	—

SECONDARY outcome

Timeframe: 6 months post-injury

Population: Subjects for whom study drug administration was started and DRS questions were obtained at 6 months. Excluded subjects include those who withdrew prior to 6 months after injury and those lost to follow-up.

The DRS is designed to classify patients based on their degree of function after brain injury. The DRS consists of 8 items that fall into 4 categories: (a) arousability, awareness and responsivity, (b) cognitive ability for self-care activities, (c) dependence on others, and (d) psychosocial adaptability. The score ranges from 0 (no disability) to 30 (death).

Outcome measures

Outcome measures
Measure	Placebo n=266 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=261 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=287 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Disability Rating Scale (DRS) at 6 Months	8.0 score on a scale Standard Deviation 11.8	8.1 score on a scale Standard Deviation 11.9	6.6 score on a scale Standard Deviation 10.8	—

SECONDARY outcome

Timeframe: At the end of the hospital stay (average of 9 days post injury)

Population: Subjects for whom study drug administration was started and for whom Glasgow Outcome Score Extended was obtained at discharge. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.

Outcome measures

Outcome measures
Measure	Placebo n=292 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=294 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=329 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Number of Participants With Unfavorable Outcome on Dichotomized Glasgow Outcome Scale Extended (GOS-E) at Discharge	196 Participants	193 Participants	228 Participants	—

SECONDARY outcome

Timeframe: At the end of the hospital stay (average of 9 days post injury)

Population: Subjects for whom study drug administration was started and for whom discharge Disability Rating Scale was obtained. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=294 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=329 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Disability Rating Scale (DRS) at Discharge	9.0 score on a scale Standard Deviation 11.1	9.4 score on a scale Standard Deviation 11.0	8.1 score on a scale Standard Deviation 9.8	—

SECONDARY outcome

Timeframe: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 13 days among patients with multiple scans)

Population: Subjects for whom study drug administration was started and for whom two or more analyzable head CT scans were obtained prior to a hematoma evacuation. Excluded subjects primarily include those who died or withdrew before an initial or second CT scan was taken, who had a hematoma evacuation prior to a second scan, or who had only one negative CT.

All clinically indicated head computed tomography (CT) scans obtained during the initial hospitalization or within the first 28 days were assessed for ICH. Parenchymal (IPH), subdural (SDH) and epidural (EDH) hemorrhage volumes were measured and quantified using volumetric software and verified by manual calculations based on the previously validated ABC/2 technique. The sum of the IPH, SDH, and EDH volumes were compared across scans. A relative increase of 33% (and at least a 1 ml increase) on any subsequent scan compared to the initial scan was defined as a progression.

Outcome measures

Outcome measures
Measure	Placebo n=148 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=154 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=178 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Number of Participants With Intracranial Hemorrhage (ICH) Progression	30 Participants	26 Participants	27 Participants	—

SECONDARY outcome

Timeframe: Initial head CT (average of 1.9 hours post-injury)

Population: Subjects who received an initial head computed tomography scan with sufficient information to be scored.

The Marshall classification categorizes patients into one of six categories (I to VI) of increasing severity on the basis of findings on non-contrast CT scan of the brain. Higher categories have worse prognosis and survival.

Outcome measures

Outcome measures
Measure	Placebo n=291 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=290 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=332 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Marshall Computed Tomography (CT) Score on Initial Head CT Diffuse injury I	120 Participants	115 Participants	134 Participants	—
Marshall Computed Tomography (CT) Score on Initial Head CT Mass lesion V/VI	46 Participants	42 Participants	46 Participants	—
Marshall Computed Tomography (CT) Score on Initial Head CT Diffuse injury II	106 Participants	117 Participants	135 Participants	—
Marshall Computed Tomography (CT) Score on Initial Head CT Diffuse injury III	12 Participants	12 Participants	12 Participants	—
Marshall Computed Tomography (CT) Score on Initial Head CT Diffuse injury IV	7 Participants	4 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Initial head CT (average of 1.9 hours post-injury)

Population: Subjects determined by the central image reviewer to have an intracranial hemorrhage (ICH) on the initial head computed tomography (CT) scan and sufficient information to assign the Rotterdam score.

The Rotterdam classification includes four independently scored elements: degree of basal cistern compression, degree of midline shift, presence of epidural hematomas, and presence of intraventricular or subarachnoid blood. The elements are combined to form an overall score from 1 to 6 with higher scores having worse prognosis and survival.

Outcome measures

Outcome measures
Measure	Placebo n=158 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=161 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=187 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT 6	5 Participants	5 Participants	3 Participants	—
Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT 1	2 Participants	1 Participants	5 Participants	—
Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT 2	32 Participants	28 Participants	36 Participants	—
Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT 3	81 Participants	91 Participants	98 Participants	—
Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT 4	17 Participants	24 Participants	28 Participants	—
Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT 5	21 Participants	12 Participants	17 Participants	—

SECONDARY outcome

Timeframe: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

Population: Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.

Neurosurgical interventions include craniotomy, craniectomy, and placement of a neuromonitoring or drainage device. Counts are of subjects with one or more neurosurgical interventions.

Outcome measures

Outcome measures
Measure	Placebo n=309 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=312 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=345 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Number of Participants With One or More Neurosurgical Interventions	54 Participants	62 Participants	75 Participants	—

SECONDARY outcome

Timeframe: From hospital admission through day 28

Population: Subjects for whom study drug administration was started and for whom discharge status was known. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.

Hospital-free days count any day from hospital admission through day 28 that the patient is alive and out of the hospital.

Outcome measures

Outcome measures
Measure	Placebo n=295 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=292 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=331 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Hospital-free Days	13.6 days Standard Deviation 10.7	13.6 days Standard Deviation 10.7	14.1 days Standard Deviation 10.4	—

SECONDARY outcome

Timeframe: From hospital admission through day 28

Population: Subjects for whom study drug administration was started and for whom number of ICU days through 28 days was known. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.

ICU-free days count any day from hospital admission through day 28 that the patient is alive and not in the ICU. Subjects who die prior to discharge (even if after 28 days) are assigned a value of 0.

Outcome measures

Outcome measures
Measure	Placebo n=295 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=293 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=331 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Intensive Care Unit (ICU)-Free Days	18.5 days Standard Deviation 10.6	18.1 days Standard Deviation 10.8	19.1 days Standard Deviation 9.7	—

SECONDARY outcome

Timeframe: From hospital admission through day 28

Population: Subjects for whom study drug administration was started and for whom number of ventilator days through 28 days was known. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.

Ventilator-free days count any day from hospital admission through day 28 that the patient is alive and does not require mechanical ventilatory support. Subjects who die prior to discharge (even if after 28 days) are assigned a value of 0.

Outcome measures

Outcome measures
Measure	Placebo n=295 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=293 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=331 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Ventilator-free Days	20.2 days Standard Deviation 10.5	19.9 days Standard Deviation 10.8	20.9 days Standard Deviation 9.7	—

SECONDARY outcome

Timeframe: From start of study drug infusion through 28 days or the end of the hospital stay if sooner (average of 9 days)

Population: Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.

Seizures may cause involuntary changes in body movement or function, sensation, awareness, or behavior. Seizures are often associated with a sudden and involuntary contraction of a group of muscles and loss of consciousness. Seizures or episodes of seizure-like activity were reported by medics in the field following the start of study drug infusion through hand-off to the trauma center and by trauma center staff through discharge. Reported events were included if providers gave anti-seizure medication and/or the event was confirmed by EEG.

Outcome measures

Outcome measures
Measure	Placebo n=309 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=312 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=345 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Number of Participants With Seizure	7 Participants	5 Participants	17 Participants	—

SECONDARY outcome

Timeframe: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

Population: Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.

Diagnosis of cerebral ischemic event

Outcome measures

Outcome measures
Measure	Placebo n=309 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=312 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=345 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Number of Participants With Cerebral Ischemic Event	10 Participants	3 Participants	13 Participants	—

SECONDARY outcome

Timeframe: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

Population: Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.

Diagnosis of an acute myocardial infarction

Outcome measures

Outcome measures
Measure	Placebo n=309 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=312 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=345 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Number of Participants With Myocardial Infarction (MI)	1 Participants	3 Participants	2 Participants	—

SECONDARY outcome

Timeframe: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

Population: Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.

Diagnosis of DVT

Outcome measures

Outcome measures
Measure	Placebo n=309 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=312 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=345 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Number of Participants With Deep Vein Thrombosis (DVT)	9 Participants	3 Participants	10 Participants	—

SECONDARY outcome

Timeframe: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

Population: Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.

Diagnosis of PE

Outcome measures

Outcome measures
Measure	Placebo n=309 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=312 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=345 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Number of Participants With Pulmonary Embolus (PE)	5 Participants	3 Participants	6 Participants	—

SECONDARY outcome

Timeframe: From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)

Population: Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.

Diagnosis of one or more of the following: cerebral ischemic event, myocardial infarction (MI), deep vein thrombosis (DVT), pulmonary embolism (PE), or any other thromboembolic event

Outcome measures

Outcome measures
Measure	Placebo n=309 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=312 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=345 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Number of Participants With Any Thromboembolic Event	30 Participants	13 Participants	31 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: First blood draw (average of 1.6 hours post-injury)

Population: Subjects with an LY30 measurement at hospital admission are included. Subjects who were transported to trauma centers without a TEG machine, who died prior to the initial blood draw, or who withdrew or refused a blood draw were excluded. Additional exclusions included blood draw missed by study staff and technical difficulties with processing.

Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on kaolin-activated thromboelastography (TEG) and defined as LY30 or the per cent lysis that occurs 30 minutes after maximum amplitude (MA) is achieved. LY30 is categorized as \<0.8% (fibrinolysis shutdown), 0.8-3% (normal), and \>3% (hyperfibrinolysis).

Outcome measures

Outcome measures
Measure	Placebo n=240 Participants Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=246 Participants 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=261 Participants 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Combined TXA Arms Includes both the Bolus-Maintenance (1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours) and Bolus Only (2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours) treatment arms.
Fibrinolysis at Hospital Admission <0.8 (fibrinolysis shutdown)	148 Participants	157 Participants	165 Participants	—
Fibrinolysis at Hospital Admission 0.8-3% (normal)	56 Participants	61 Participants	65 Participants	—
Fibrinolysis at Hospital Admission >3% (hyperfibrinolysis)	36 Participants	28 Participants	31 Participants	—

Adverse Events

Placebo

Serious events: 25 serious events

Other events: 81 other events

Deaths: 50 deaths

Bolus-Maintenance

Serious events: 13 serious events

Other events: 74 other events

Deaths: 53 deaths

Bolus Only

Serious events: 24 serious events

Other events: 92 other events

Deaths: 40 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=309 participants at risk Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus-Maintenance n=312 participants at risk 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours.	Bolus Only n=345 participants at risk 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/309 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.32% 1/312 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.29% 1/345 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Cardiac disorders Myocardial infarction (MI)	0.32% 1/309 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.64% 2/312 • Number of events 2 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.29% 1/345 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Nervous system disorders Cerebrovascular accident - hemorrhagic	0.65% 2/309 • Number of events 2 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.96% 3/312 • Number of events 3 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.00% 0/345 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Nervous system disorders Cerebrovascular accident - thrombotic	2.9% 9/309 • Number of events 10 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.32% 1/312 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	3.2% 11/345 • Number of events 11 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Nervous system disorders Seizures	0.65% 2/309 • Number of events 2 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.96% 3/312 • Number of events 3 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	1.7% 6/345 • Number of events 6 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism (PE)	0.97% 3/309 • Number of events 3 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.64% 2/312 • Number of events 2 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	1.2% 4/345 • Number of events 4 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Vascular disorders Cerebral vascular emboli	0.32% 1/309 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.00% 0/312 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.29% 1/345 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Vascular disorders Cerebral venus sinus thrombosis	1.3% 4/309 • Number of events 4 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.00% 0/312 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	1.2% 4/345 • Number of events 4 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Vascular disorders Deep vein thrombosis (DVT)	1.3% 4/309 • Number of events 5 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.32% 1/312 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	1.4% 5/345 • Number of events 5 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Vascular disorders Embolic infarcts	0.00% 0/309 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.00% 0/312 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.29% 1/345 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Vascular disorders Inferior vena cava thrombus	0.00% 0/309 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.00% 0/312 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.29% 1/345 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Vascular disorders Internal jugular vein thrombus	0.32% 1/309 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.00% 0/312 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.00% 0/345 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Vascular disorders Left ventricular thrombus	0.32% 1/309 • Number of events 1 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.00% 0/312 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.	0.00% 0/345 • Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators. Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.

Other adverse events

Additional Information

Dr. Susanne May

University of Washington, Resuscitation Outcomes Consortium

Phone: 206-685-1302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60