氨甲环酸对行开颅术创伤性脑损伤患者预后的影响：一项随机对照试验的研究方案。
Effect of tranexamic acid on the prognosis of patients with traumatic brain injury undergoing craniotomy: study protocol for a randomised controlled trial.
机构信息
Department of Anaesthesiology, Beijing Tian Tan hospital, Capital Medical University, Beijing, China.
Department of Anaesthesiology, Beijing Tian Tan hospital, Capital Medical University, Beijing, China
出版信息
BMJ Open. 2021 Nov 25;11(11):e049839. doi: 10.1136/bmjopen-2021-049839.
Abstract
INTRODUCTION
Abnormal coagulation function aggravates the prognosis of patients with traumatic brain injury (TBI). It was reported that the antifibrinolytic drug tranexamic acid (TXA) could reduce intracranial haemorrhage and mortality in non-operative patients with TBI. However, there is a lack of evaluation of TXA in patients with TBI undergoing craniotomy.
METHODS AND ANALYSIS
This is a single-centre randomised controlled, double-blind, parallel study aiming to investigate the effectiveness and safety of TXA in patients with TBI during the perioperative period. Blood loss and transfusion, neurological function, adverse events, mortality and serum immune-inflammatory cytokines will be collected and analysed.
ETHICS AND DISSEMINATION
Ethical approval has been granted by the Medical Ethics Committee of Beijing Tian Tan Hospital, Capital Medical University (reference number KY 2020-136-03). The results of this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
ChiCTR2100041911.
摘要
简介
凝血功能异常会加重创伤性脑损伤（TBI）患者的预后。有报道称，抗纤维蛋白溶解药物氨甲环酸（TXA）可降低非手术 TBI 患者的颅内出血和死亡率。然而，对于接受开颅手术的 TBI 患者，TXA 的疗效尚缺乏评估。
方法与分析
这是一项单中心、随机对照、双盲、平行研究，旨在探讨围手术期 TXA 对 TBI 患者的有效性和安全性。将收集并分析失血量和输血、神经功能、不良事件、死亡率和血清免疫炎症细胞因子。
伦理与传播
本研究已获得首都医科大学附属北京天坛医院医学伦理委员会的批准（编号 KY 2020-136-03）。本研究结果将通过科学会议的演示和同行评议期刊的发表进行传播。
临床试验注册号
ChiCTR2100041911。
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