Cerebral Hemorrhage
Conditions
Keywords
double blind randomized trial, spontaneous intracerebral hemorrhage, tranexamic acid
Brief summary
Intracerebral hemorrhage is increasingly becoming a major burden in the society because of significant morbidity as well as mortality. Hematoma volume at the time of presentation as well as hematoma expansion and re-bleed or ongoing bleed further deteriorates the patient making a poor prognosis, however at present no therapy targets this pathological process. Though clinical studies do report benefit of using tranexamic acid in spontaneous intracerebral hemorrhage by reducing hematoma expansion rate as well as decreasing ongoing bleed, large randomized controlled trials have not shown any convincing advantage owing to various limitations in their design and methods. However, they uniformly did not find any significant side effect with the use of tranexamic acid. The aim of this study is to test the hypothesis that intravenous tranexamic acid is superior to placebo by reducing hematoma expansion when given within 24 h of spontaneous intracerebral hemorrhage.
Detailed description
Patients and Methods: Data are being collected as patient gets admitted with Intracerebral haemorrhage. 154 spontaneous intracerebral haemorrhage patients presenting within 24 hours of ictus or last known well will be taken in the study. Outcomes of these patients will be calculated to establish a relationship between hematoma expansion, underlying pathology and outcome of the patients. Results: Primary outcome i.e. radiological improvement (CT scan): Difference between hematoma volume with perilesional edema from baseline and 48-hour post treatment scan, hematoma location, and new infarction. Secondary outcomes: Neurological impairment (NIHSS), Disability (Barthel index), dependency (mRS) on day of discharge. mRS at day 30. Cognition (Telephone Interview Cognition Score-Modified), dependency (mRS) at days 90 and 180. Similarly, costs of treatment between two groups, length of stay in hospital and f/u data. Also, Safety endpoints recorded until day 180: Death (cause), venous thromboembolism confirmed by ultrasound, vascular occlusive events (stroke/transient ischemic attack/myocardial infarction/peripheral artery disease), seizures. Serious adverse events (AEs) in first seven days will be analyzed and calculated.
Interventions
Loading dose of trial (1g of tranexamic acid in 10ml) is mixed in 100ml sodium chloride 0.9% and given over 10 minutes. Maintenance dose of trial mixed in 500ml sodium chloride 0.9% is given over 8 hours
Sponsors
Kathmandu Medical College and Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. All patients presenting to the emergency department with symptom of hemorrhagic stroke within 24 hours from onset of symptom or last seen well. 2. Patient who had a follow up
Exclusion criteria
1. Glasgow coma scale \<8 after resuscitation (as this can lead to biasness; requires surgery) 2. Contraindication to tranexamic acid, 3. Hemorrhagic stroke secondary to trauma, 4. Hemorrhage was caused by coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological improvement (CT scan) | 48 hour | Difference between hematoma volume from baseline and 48-hour post treatment scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale | day 10 | Neurological impairment (score:0-42; 0:favourable outcome) |
| Barthel index | days 10 | Disability (score:0-100; 100: independent) |
| modified rankin scale | days 10 and 30, 90, 180 | dependency (score:0-5; 0: no symptom) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Death | day 180 | Number of death |
Countries
Nepal
Outcome results
None listed