Department of Intensive Care, Amsterdam UMC Location Vrije Universiteit, Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.
Department of Anesthesiology, Amsterdam UMC Location Vrije Universiteit, Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.
Trials. 2024 Aug 2;25(1):520. doi: 10.1186/s13063-024-08332-1.
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.
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.
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.
EudraCT: 2020-005405-10; ClinicalTrial.gov: NCT05507983 (retrospectively registered in August 2022, inclusion started in December 2021).
尽管知识有所增加，但烧伤切痂术中的失血仍然是一个主要挑战，是死亡率的独立预测因素。在烧伤手术中，控制出血的手段有限。纤溶亢进可能是烧伤切痂术中失血的原因之一。氨甲环酸可抑制纤溶反应，少量证据表明氨甲环酸对出血量有积极影响。
本研究的主要目的有两个，（1）研究氨甲环酸是否可减少出血量，（2）研究烧伤创伤后和烧伤切痂术中的凝血变化。本研究是在荷兰烧伤中心内进行的多中心、双盲、随机临床试验。所有预计出血量≥250 且计划行烧伤切痂术的成年患者均有资格入组本研究。该研究旨在使干预组的出血量减少 25%。总共将纳入 95 名患者。干预组将接受 1500mg 氨甲环酸，而另一组则给予安慰剂。主要终点是减少出血量。次要终点包括手术期间纤溶的发生、游离皮片移植的成活率、凝血和血凝块形成的差异。
本随机对照试验方案旨在研究氨甲环酸在减少烧伤切痂术中失血的效果。此外，本研究旨在阐明烧伤创伤后和手术过程中的凝血状态。
EudraCT：2020-005405-10；ClinicalTrials.gov：NCT05507983（2022 年 8 月回顾性注册，纳入于 2021 年 12 月开始）。
