NCT04742205

ITCH Trial: 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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Kathmandu Medical College and Teaching Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic Acid 500 MG	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

Timeline

• Start date: 2021-02-08
• Primary completion: 2023-12-05
• Completion: 2024-06-04
• First posted: 2021-02-08
• Last updated: 2025-03-19

Locations

1 site across 1 country: Nepal