Tranexamic acid for IntraCerebral Haemorrhage (TICH-2): a pragmatic phase III prospective double-blind randomised placebo-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,325
研究概览
简要总结
2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27048694 protocol 2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29431141 sub-study protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29778325 results 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31322116 results (added 22/07/2019) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31735141 CT results in (added 19/11/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/32902808/ results (added 11/09/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33586453/ results (added 16/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34000834/ (added 19/05/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35311937/ Substudy results (added 22/03/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37337529/ Secondary analysis (added 20/06/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Adult (=18 years, either sex) patients with acute primary intracerebral haemorrhage (PICH) within 8 hours of stroke onset (where stroke onset time is unknown, the time of when last known well will be used)
排除标准
- •1. Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis or known underlying structural abnormality such as arterial venous malformation, aneurysm, tumour, venous thrombosis as cause for the intracerebral haemorrhage. Note it is not necessary to exclude an underlying abnormality prior to enrolment, but where a secondary cause of haemorrhage is known, these patients should not be recruited.
- •2. Patients for whom tranexamic acid is thought to be contraindicated
- •3. Patients with premorbid dependency (mRS>4)
- •4. Participation in another drug trial concurrently
- •5. Prestroke life expectancy <3 months (e.g. advanced metastatic cancer)
- •6. Coma ? Glasgow coma scale <5