TRANexamic Acid to Reduce Bleeding in BURN Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-22

Study Completion Date

2021-11-13

Brief Summary

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Excision and grafting in burn patients can lead to severe blood loss. A preliminary study conducted in Saint Joseph Saint Luc Hospital showed that the total median blood loss was 1412 mL (1). Transfused patients had a total median blood loss of 2468 mL and an average number of 4 packed red blood cells (PRBC) administered.

Among the various methods that help limit blood loss, tranexamic acid, which has been proved useful in traumatology and surgery, has not been sufficiently studied in burn patients. A preliminary study in 27 burned patients showed a reduction of blood loss with tranexamic acid (2).

Objective of TRANBURN study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.

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Detailed Description

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The first aim of the study is to demonstrate that tranexamic acid help limit blood loss and reduces the use of blood products.

Secondary objectives are to evaluate impact of tranexamic acid on mortality, success of skin grafts and occurrence of deep vein thrombosis or myocardial infarction.

Conditions

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Tranexamic Acid Burns Surgery Wounds and Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tranexamic Acid

Patient will receive:

* 1g of tranexamic acid by slow intravenous injection
* 1g of tranexamic acid by syringe pump during 8 hours

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Placebo

Patient will receive:

* 10 mL of 0.9% sodium chloride by slow intravenous injection
* 48 mL of 0.9% sodium chloride by syringe pump during 8 hours

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0.9% sodium chloride to mimic tranexamic acid

Interventions

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Tranexamic Acid

Intervention Type DRUG

Placebo

0.9% sodium chloride to mimic tranexamic acid

Intervention Type DRUG

Other Intervention Names

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Exacyl 0.9% sodium chloride

Eligibility Criteria

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Inclusion Criteria

* Subjects undergoing burn excision surgery for standard of care purposes
* Male or female \>= 18 years of age
* Subject or subject's medical decision maker agrees to participate in this study and provides informed consent

Exclusion Criteria

* Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary embolism
* Renal impairment
* Subjects with known hypersensitivity to tranexamic acid
* Consecutive fibrinolytic states to coagulopathy
* History of convulsions

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No