Effectiveness of Intravenous Tranexamic Acid in Primary Cerebral Hemorrhage for Prevention of Hematoma Progression: Protocol for a Randomized, Double Blind Placebo-controlled Trial
Effectiveness of Intravenous Tranexamic Acid in Primary Cerebral Hemorrhage for Prevention of Hematoma Progression: Protocol for a Randomized, Double Blind Placebo-controlled Trial
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.
Patients and Methods: Data will be collected (after Nepal Health Research Council approval)
 for 1 year as patient gets admitted with Intracerebral haemorrhage. 160 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 (National Institutes of Health Stroke Scale) at
 day 7, Outcome: Dependency (modified Ranking Scale), Cognition (Telephone Interview Cognition
 Score-Modified), and mood (Zung Depression Scale) at days 10 and 90 and 180. Similarly,
 costs: Length of stay in hospital, readmission, ability to return back to daily activities.
 Also, Safety endpoints recorded until day 90: 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.
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 <9 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