Trial Outcomes & Findings for TXA Study in Major Burn Surgery (NCT NCT02753816)

Results Overview

To determine the impact of perioperative administration of Tranexamic Acid on blood loss in major burn surgeries.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Intraoperative, average 122 minutes

Results posted on

2021-08-23

Participant Flow

Enrolled participants can have multiple surgeries during the course of their stay. This is the reason for the discrepancy between the protocol enrollment and the participant flow.

Unit of analysis: Number of surgeries

Participant milestones

Participant milestones
Measure	Tranexamic Acid 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Tranexamic Acid	Placebo Placebo given over 10 minutes into the vein once prior to surgery Placebo Comparator	Tranexamic Acid and Placebo Patients whom received Tranexamic Acid during one surgery and Placebo in another surgery
Overall Study STARTED	7 9	11 11	7 22
Overall Study Tranexamic Acid	7 9	0 0	7 12
Overall Study Placebo	0 0	11 11	7 10
Overall Study COMPLETED	7 9	10 10	7 22
Overall Study NOT COMPLETED	0 0	1 1	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Tranexamic Acid 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Tranexamic Acid	Placebo Placebo given over 10 minutes into the vein once prior to surgery Placebo Comparator	Tranexamic Acid and Placebo Patients whom received Tranexamic Acid during one surgery and Placebo in another surgery
Overall Study Protocol Violation	0	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tranexamic Acid n=7 Participants 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Tranexamic Acid	Placebo n=11 Participants Placebo given over 10 minutes into the vein once prior to surgery Placebo Comparator	Tranexamic Acid and Placebo n=7 Participants (see participant flow)	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=7 Participants	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=7 Participants	8 Participants n=11 Participants	6 Participants n=7 Participants	21 Participants n=25 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants	3 Participants n=11 Participants	1 Participants n=7 Participants	4 Participants n=25 Participants
Age, Continuous	37.2 years n=7 Participants	53.7 years n=11 Participants	48.6 years n=7 Participants	47.6 years n=25 Participants
Sex: Female, Male Female	1 Participants n=7 Participants	5 Participants n=11 Participants	1 Participants n=7 Participants	7 Participants n=25 Participants
Sex: Female, Male Male	6 Participants n=7 Participants	6 Participants n=11 Participants	6 Participants n=7 Participants	18 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 Participants n=7 Participants	11 Participants n=11 Participants	7 Participants n=7 Participants	25 Participants n=25 Participants

PRIMARY outcome

Timeframe: Intraoperative, average 122 minutes

Population: 1 patient in the Placebo group was excluded from this analysis. Patient was randomized to treatment but never received the treatment intraoperatively. 1 additional patient from the Placebo group was also excluded due to the missing data required to calculate intraoperative blood loss.

To determine the impact of perioperative administration of Tranexamic Acid on blood loss in major burn surgeries.

Outcome measures

Outcome measures
Measure	Tranexamic Acid n=14 Participants 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Tranexamic Acid	Placebo n=15 Participants Placebo given over 10 minutes into the vein once prior to surgery Placebo Comparator
Intraoperative Blood Loss in mL	100 mL Interval 100.0 to 200.0	325 mL Interval 200.0 to 500.0

PRIMARY outcome

Timeframe: First burn surgery to hospital discharge

Population: 1 patient in the Placebo group was excluded from this analysis. Patient was randomized to treatment but never received the treatment intraoperatively. 1 additional patient from the Placebo group was also excluded due the missing data required to calculate transfusion rate . 1 patient from the Tranexamic Acid group was excluded due to missing data required to calculate transfusion rate.

To determine the impact of perioperative administration of Tranexamic Acid on transfusion rates in major burn surgeries.

Outcome measures

Outcome measures
Measure	Tranexamic Acid n=13 Participants 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Tranexamic Acid	Placebo n=15 Participants Placebo given over 10 minutes into the vein once prior to surgery Placebo Comparator
Blood Transfusion Rates, Defined Nominally (Binary) as Having at Least One Transfusion	2 Patients with 1 or more transfusions	3 Patients with 1 or more transfusions

SECONDARY outcome

Timeframe: Hospital admission to hospital discharge

Population: For this analysis we compared patients that only received either Tranexamic Acid or Placebo. 3 patients from the Tranexamic Acid group and 2 from the Placebo group were not included in the analysis due to missing data on their length of stay.

To determine the impact of Tranexamic Acid on total hospital length of stay by comparing the hospital admission date and the hospital discharge date. This determination will take into account current burn size and location, procedures performed and their effect on wound healing and skin graft survival.

Outcome measures

Outcome measures
Measure	Tranexamic Acid n=5 Participants 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Tranexamic Acid	Placebo n=8 Participants Placebo given over 10 minutes into the vein once prior to surgery Placebo Comparator
Effect of Tranexamic Acid on the Total Length of Hospital Admission for a Large (350 cm2) Burn Injury	23 Days Interval 10.0 to 29.0	9 Days Interval 5.0 to 23.0

Adverse Events

Tranexamic Acid

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tranexamic Acid n=14 participants at risk 1 gram of Tranexamic Acid given over 10 minutes into the vein once prior to surgery Tranexamic Acid	Placebo n=17 participants at risk Placebo given over 10 minutes into the vein once prior to surgery Placebo Comparator
Cardiac disorders NSTEMI	0.00% 0/14 • Hospital admission to hospital discharge	5.9% 1/17 • Number of events 1 • Hospital admission to hospital discharge
Vascular disorders Pulmonary Embolism	7.1% 1/14 • Number of events 1 • Hospital admission to hospital discharge	0.00% 0/17 • Hospital admission to hospital discharge
Cardiac disorders Acute Myocardial Infarction	7.1% 1/14 • Number of events 1 • Hospital admission to hospital discharge	0.00% 0/17 • Hospital admission to hospital discharge

Other adverse events

Adverse event data not reported

Additional Information

Dr. Betsy Steensma

Spectrum Health

Phone: (616) 391-5701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place