Trial Outcomes & Findings for Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial) (NCT NCT02086500)
NCT ID: NCT02086500
Last Updated: 2020-09-10
Results Overview
Because not all patients had available data regarding 30-day mortality (patients were discharged and there 30-day outcome was unable to be determined) there may be differences between the 30Day mortality relative to the other outcomes. There were 5 and 4 patients from each arm that did not have 30-day outcome and thus are different.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
903 participants
Primary outcome timeframe
30 Day
Results posted on
2020-09-10
Participant Flow
Participant milestones
| Measure |
Prehospital Tranexamic Acid
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
|---|---|---|
|
Overall Study
STARTED
|
447
|
456
|
|
Overall Study
COMPLETED
|
447
|
456
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
Baseline characteristics by cohort
| Measure |
Prehospital Tranexamic Acid
n=447 Participants
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
n=456 Participants
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
Total
n=903 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
n=5 Participants
|
39 years
n=7 Participants
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
327 Participants
n=5 Participants
|
341 Participants
n=7 Participants
|
668 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
353 Participants
n=5 Participants
|
361 Participants
n=7 Participants
|
714 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 DayPopulation: Because not all patients had available data regarding 30-day mortality (patients were discharged and there 30-day outcome was unable to be determined) there may be differences between the 30Day mortality relative to the other outcomes. There were 5 and 4 patients from each arm that did not have 30-day outcome and thus are different.
Because not all patients had available data regarding 30-day mortality (patients were discharged and there 30-day outcome was unable to be determined) there may be differences between the 30Day mortality relative to the other outcomes. There were 5 and 4 patients from each arm that did not have 30-day outcome and thus are different.
Outcome measures
| Measure |
Prehospital Tranexamic Acid
n=442 Participants
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
n=452 Participants
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
|---|---|---|
|
30 Day Mortality
|
36 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 24 HoursOutcome measures
| Measure |
Prehospital Tranexamic Acid
n=447 Participants
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
n=453 Participants
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
|---|---|---|
|
24 Hour Mortality
|
16 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Prehospital Tranexamic Acid
n=447 Participants
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
n=453 Participants
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
|---|---|---|
|
Acute Lung Injury
|
42 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Prehospital Tranexamic Acid
n=447 Participants
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
n=453 Participants
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
|---|---|---|
|
Multiple Organ Failure
|
33 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Prehospital Tranexamic Acid
n=447 Participants
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
n=453 Participants
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
|---|---|---|
|
Nosocomial Infection
|
88 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Prehospital Tranexamic Acid
n=447 Participants
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
n=453 Participants
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
|---|---|---|
|
24 Hour Total Blood Transfusion
|
0 units of blood transfusion
Interval 0.0 to 2.0
|
0 units of blood transfusion
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Prehospital Tranexamic Acid
n=447 Participants
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
n=453 Participants
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
|---|---|---|
|
Hyperfinbrinolysis
|
145 Participants
|
144 Participants
|
Adverse Events
Prehospital Tranexamic Acid
Serious events: 4 serious events
Other events: 4 other events
Deaths: 36 deaths
Control
Serious events: 7 serious events
Other events: 14 other events
Deaths: 45 deaths
Serious adverse events
| Measure |
Prehospital Tranexamic Acid
n=447 participants at risk
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
n=456 participants at risk
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.22%
1/447 • Number of events 1 • Hospital Admission to 30 days
|
0.44%
2/456 • Number of events 2 • Hospital Admission to 30 days
|
|
Cardiac disorders
MI
|
0.00%
0/447 • Hospital Admission to 30 days
|
0.22%
1/456 • Number of events 1 • Hospital Admission to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolus
|
0.00%
0/447 • Hospital Admission to 30 days
|
0.22%
1/456 • Number of events 1 • Hospital Admission to 30 days
|
|
Nervous system disorders
Seizure
|
0.22%
1/447 • Number of events 1 • Hospital Admission to 30 days
|
0.22%
1/456 • Number of events 1 • Hospital Admission to 30 days
|
|
Blood and lymphatic system disorders
Arterial Thromboembolic event NOS
|
0.45%
2/447 • Number of events 2 • Hospital Admission to 30 days
|
0.44%
2/456 • Number of events 2 • Hospital Admission to 30 days
|
Other adverse events
| Measure |
Prehospital Tranexamic Acid
n=447 participants at risk
1 gram of Tranexamic Acid will be given during emergency medical transport
Tranexamic Acid: 1 gram of prehospital Tranexamic Acid
|
Control
n=456 participants at risk
Identical volume of saline during emergency medical transport
Saline control: Saline Control
|
|---|---|---|
|
Gastrointestinal disorders
ileus
|
0.22%
1/447 • Number of events 1 • Hospital Admission to 30 days
|
0.22%
1/456 • Number of events 1 • Hospital Admission to 30 days
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.22%
1/447 • Number of events 1 • Hospital Admission to 30 days
|
0.00%
0/456 • Hospital Admission to 30 days
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/447 • Hospital Admission to 30 days
|
0.22%
1/456 • Number of events 1 • Hospital Admission to 30 days
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/447 • Hospital Admission to 30 days
|
0.22%
1/456 • Number of events 1 • Hospital Admission to 30 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/447 • Hospital Admission to 30 days
|
0.22%
1/456 • Number of events 1 • Hospital Admission to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolus
|
0.22%
1/447 • Number of events 1 • Hospital Admission to 30 days
|
0.00%
0/456 • Hospital Admission to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pnuemonitis
|
0.00%
0/447 • Hospital Admission to 30 days
|
0.22%
1/456 • Number of events 1 • Hospital Admission to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/447 • Hospital Admission to 30 days
|
0.22%
1/456 • Number of events 1 • Hospital Admission to 30 days
|
|
Nervous system disorders
Seizure
|
0.00%
0/447 • Hospital Admission to 30 days
|
0.44%
2/456 • Number of events 2 • Hospital Admission to 30 days
|
|
Nervous system disorders
Stroke
|
0.00%
0/447 • Hospital Admission to 30 days
|
0.44%
2/456 • Number of events 2 • Hospital Admission to 30 days
|
|
Blood and lymphatic system disorders
Venous Thromboembolic Event NOS
|
0.00%
0/447 • Hospital Admission to 30 days
|
0.22%
1/456 • Number of events 1 • Hospital Admission to 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.22%
1/447 • Number of events 1 • Hospital Admission to 30 days
|
0.66%
3/456 • Number of events 3 • Hospital Admission to 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place