Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage
Trial Parameters
Brief Summary
This multicenter, pragmatic randomized, open-label clinical trial aims to assess whether Tranexamic Acid improves outcomes in adult patients with spontaneous intracerebral haemorrhage. The participants presenting within 4.5 hours of the onset of symptoms of stroke with intracerebral haemorrhage confirmed on Computed Tomography (CT Scan) will be randomized into two groups in a 1:1 ratio using a central online randomization. The treatment arm will consist of giving intravenously 2 grams of Tranexamic Acid in 100 ml 0.9% sodium chloride administered over 45 minutes. Control arm patients will receive standard of care treatment as per the institutional protocol. In both arms, intensive systolic blood pressure reduction to less than 140 mmHg will be done using antihypertensive medications, which has to be achieved within one hour and will be maintained over next seven days. The choice of antihypertensive drug will depend on the clinician's preference. Both groups will have a repeat CT scan after 24 hours to check for any increase in the haematoma volume. Any deterioration in the neurological status will warrant urgent brain imaging. On day 7, the patient will be assessed for their NIHSS score and mRS score. On day 90, quality of life and the functional outcome will be assessed.
Eligibility Criteria
Inclusion Criteria: Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms Exclusion Criteria: 1. Patients with ICH secondary to anticoagulation, thrombolysis, or known underlying structural abnormality such as arteriovenous malformation, aneurysm, tumor, venous thrombosis or due to known hereditary coagulation disorders. 2. Contraindication to TXA. 3. Concurrent participation in another trial. 4. Pre-stroke life expectancy \<3 months (e.g. advanced metastatic cancer). 5. Glasgow coma scale (GCS) ⩽5. 6. ICH secondary to trauma. 7. Women of childbearing potential, pregnant, or breastfeeding at randomization. 8. Geographical or other factors that prohibit follow-upto 90 days. 9. Concurrent or planned treatment with any other hemostatic agents. 10. ICH volume \>60 mL as measured by ABC/2 method.