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. 2024 Aug 2;25(1):520.
doi: 10.1186/s13063-024-08332-1.

Efficacy of tranexamic acid versus placebo in reducing blood loss during burn excisional surgery: a multi-center, double-blind, parallel, randomized placebo-controlled clinical trial (TRANEX)

R K Gigengack #  1   2   3 , J Slob #  4 , A Meij-de Vries  5 , E Bosma  6 , S A Loer  7 , J S H A Koopman  8 , C H van der Vlies  4   9
Affiliations

Efficacy of tranexamic acid versus placebo in reducing blood loss during burn excisional surgery: a multi-center, double-blind, parallel, randomized placebo-controlled clinical trial (TRANEX)

R K Gigengack et al. Trials. .

Abstract

Background: Despite an increase in knowledge, blood loss during burn excisional surgery remains a major challenge and is an independent predictor of mortality. During burn surgery, limited measures are available to control the bleeding. Increased fibrinolysis could be one of the contributing factors of blood loss during burn excisional surgery. Tranexamic acid inhibits the fibrinolytic response, and a small body of evidence shows positive effects of tranexamic acid on the volume of blood loss.

Methods: The main objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces blood loss and (2) to investigate the changes in coagulation after burn trauma and during burn excisional surgery. This study is a multicenter double-blind randomized clinical trial in patients scheduled for burn excisional surgery within the Dutch burn centers. All adult patients scheduled for burn surgery with an expected blood loss of ≥ 250 are eligible for inclusion in this study. The study is powered on a blood loss reduction of 25% in the intervention group. In total, 95 subjects will be included. The intervention group will receive 1500 mg tranexamic acid versus placebo in the other group. Primary endpoint is reduction of blood loss. Secondary endpoints include occurrence of fibrinolysis during surgery, graft take of the split skin graft, and differences in coagulation and blood clot formation.

Discussion: This protocol of a randomized controlled trial aims to investigate the efficacy of tranexamic acid in reducing blood loss during burn excisional surgery. Furthermore, this study aims to clarify the coagulation status after burn trauma and during the surgical process.

Trial registration: EudraCT: 2020-005405-10; ClinicalTrial.gov: NCT05507983 (retrospectively registered in August 2022, inclusion started in December 2021).

Keywords: Blood loss; Burns; Excisional surgery; Fibrinolysis; Tranexamic acid.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT figure, schedule of enrolment, interventions, and assessments. -t1: > 24 h before surgery; t1: pre-surgery; t2: after anesthesia induction but before incision; t3: 1 h after incision; t4: during closure if total surgery time > 1.5 h; t5: end of surgery; t6: > 6 h after finishing surgery. Blood samples: hemoglobin, electrolytes (sodium/potassium), kidney function (urea/creatinine), albumin. Basic coagulation: INR, APTT, thrombocytes and fibrinogen. Additional coagulation: plasminogen activator inhibitor, D-dimer, global fibrinolysis, thrombin generation fVII, von-Willebrand Factor and anti-thrombin III and stored serum. Complications: cardiopulmonary or neurologic complication within the 3 months after the study period. ROTEM, rotational thromboelastometry
See this image and copyright information in PMC

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