Indian Trial of Tranexamic acid in Spontaneous intracerebral haemorrhage - INTRINSIC TRIA

Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年4月3日

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•Adult patients aged more than 18 years of age presenting with non-traumatic intracerebral haemorrhage within 4.5 hours of symptom onset.

•1.Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis or known underlying structural abnormality such as arteriovenous malformation, aneurysm, tumour or venous thrombosis or due to known hereditary coagulation disorders. An underlying structural abnormality does not need to be excluded before enrolment, but where known, patients should not be recruited.
•2.Known allergies to Tranexamic acid.
•3.Modified Rankin scale score >4 at the time of enrollment
•4.Concurrent participation in another drug or device trial.
•5.Pre stroke life expectancy <3 months (e.g. advanced metastatic cancer).
•6.Glasgow coma scale <7.
•7.ICH secondary to trauma.
•8.Women pregnant,or breastfeeding at randomization.
•9.Geographical or other factors that prohibit follow up at 90 days, e.g. no fixed address or telephone contact number, or overseas visitor.
•10.Planned surgery for ICH within 24 hours.
•11.Concurrent or planned treatment with any other haemostatic agents.
•12.ICH volume >60 ml as measured by the ABC/2 method.

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