Indian Trial of Tranexamic acid in Spontaneous intracerebral haemorrhage
- Conditions
- Health Condition 1: I610- Nontraumatic intracerebral hemorrhage in hemisphere, subcortical
- Registration Number
- CTRI/2023/03/050224
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death at day 7Timepoint: 7 Days
- Secondary Outcome Measures
Name Time Method 1)Radiological (CT scan): Change in hematoma volume from baseline to 24 h scan, hematoma location, and new infarction.Timepoint: 24 hours;2)Neurological impairment (NIHSS) at day 7 (or discharge if sooner).Timepoint: Day 7;3)Dependency using the seven-level modified Rankin Scale (mRS) at day 90Timepoint: 90 Days;4)Quality of Life ( EQ-5D) at days 90Timepoint: 90 Days