Health Condition 1: I610- Nontraumatic intracerebral hemorrhage in hemisphere, subcortical
Conditions
Interventions
Intervention1: Tranexamic acid: Patients admitted with sICH and presenting within 4.5 hours will receive 2 grams of Tranexamic acid as bolus doze (once) intravenously in 100 ml normal saline over 45 m
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients aged more than 18 years of age presenting with non-traumatic intracerebral haemorrhage(confirmed by CT/MRI)within 4.5 hours of symptom onset.
Exclusion criteria
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 less than3 months (e.g. advanced metastatic cancer). 5. Glasgow coma scale (GCS) less than equal to 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 more than 60 mL as measured by ABC/2 method.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality at Day 30Timepoint: 30 Day | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Jeyaraj D Pandian
Christian Medical College and Hospital, Ludhiana
Outcome results
None listed