Effect of tranexamic acid on the prognosis of patients with traumatic brain injury undergoing craniotomy: study protocol for a randomised controlled trial

IntroductionAbnormal 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 e...

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Published inBMJ open Vol. 11; no. 11; p. e049839
Main Authors Wu, Bei, Lu, Yu, Yu, Yun, Yue, Hongli, Wang, Jie, Chong, Yingzi, Cui, Weihua
Format Journal Article
LanguageEnglish
Published London British Medical Journal Publishing Group 25.11.2021
BMJ Publishing Group LTD
BMJ Publishing Group
SeriesProtocol
Subjects
Anaesthesia
anaesthesia in neurology
Antifibrinolytic agents
bleeding disorders & coagulopathies
Brain research
Clinical outcomes
Coma
Hypotheses
Informed consent
Medical prognosis
Mortality
neurological injury
Neurosurgery
Objectives
Patients
Quality control
Thrombosis
Traumatic brain injury
Beijing China
China
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Summary:IntroductionAbnormal 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 analysisThis 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 disseminationEthical 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 numberChiCTR2100041911.
Bibliography:Protocol
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2021-049839