Tranexamic Acid During Excisional Burn Surgery
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- Blood loss
研究概览
简要总结
The purpose of this study is to access the efficacy of the drug tranexamic acid in reducing blood loss during burn excision surgery.
详细描述
This study is a double-blinded, randomized placebo-controlled trial. After informed consent patients will be randomized in either the placebo or the tranexamic acid group (1500 mg). The intervention will be conducted during burn excisional surgery. First, the participant with be anesthetized, whereafter the study medication is administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for burn excisional surgery
- •An expected blood loss of ≥250ml based on the estimation by the performing surgeon on the basis of: (1) ≥ 2 % body surface area excision planned (100-200 cc / % total body surface area, (2) operation technique used (some techniques show more blood loss than others), (3) time after burn trauma (i.e. expected healing)
- •informed consent of patient or legal representative
- •Patients or legal representative should have enough knowledge of Dutch to provide informed consent
排除标准
- •Patients with a recorded coagulopathy in their history
- •The use of anticoagulants (except acetylsalicylic acid or (intensive) prophylaxis low molecular weight heparin >12 hours before surgery)
- •Severe kidney failure (creatinine >500 μmol/L)
- •Allergy for tranexamic acid
- •Diagnosis of acute venous-/arterial thrombosis within 3 months before inclusion
- •Diffuse intravascular coagulation (based on the diffuse intranasal coagulation-score >5)
- •Pregnancy
- •Active breastfeeding
- •History of epilepsy
研究组 & 干预措施
Tranexamic acid arm
Tranexamic acid 1500 mg dissolved in 100 ml sodium chloride, once, directly after anesthetizing the participant.
In participants with renal insufficiency (creatinine >120 umol/L) the dose will be reduced to 1000 mg.
干预措施: Tranexamic acid (Drug)
Placebo arm
100ml sodium chloride 0.9%, once, directly after anesthetizing the participant.
干预措施: Placebo (Drug)
结局指标
主要结局
Blood loss
时间窗: During burn excisional surgery
Volume of blood loss measured during surgery.
次要结局
- Hospital Mortality(During total admittance of the patient)
- Length of stay in days(The length of stay will be evaluated after 3 months after inclusion. If, after 3 months, the patient is still admitted, the status of hospitalisation will be check after an addition 3 months.)
- Graft failure in % of total graft(During burn excisional surgery)
- Cardiopulmonary complications(Within the first 30 days after burn excisional surgery)
- Neurologic complications(Within the first 30 days after burn excisional surgery)
- The need for escape medication(During burn excisional surgery)
- Extend of fibrinolysis during burn excisional surgery(During burn excisional surgery)
- Strength of blood clot(During burn excisional surgery)
- Transfusion requirements(Perioperative, within the first day after surgery.)