ITCH Trial: Protocol for a Randomized, Double Blind Placebo-controlled Trial

Cerebral Hemorrhage Clinical Trial

Official title: Effectiveness of Intravenous Tranexamic Acid in Primary Cerebral Hemorrhage for Prevention of Hematoma Progression: Protocol for a Randomized, Double Blind Placebo-controlled Trial

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Patients and Methods: Data are being collected as patient gets admitted with Intracerebral haemorrhage. 142 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) and Glasgow outcome scale on day of discharge and day 30. Cognition (Telephone Interview Cognition Score-Modified), dependency (mRS) and Glasgow outcome scale at days 90 and 180. Similarly, costs: Length of stay in hospital, readmission, ability to return back to daily activities. 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. ;

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage

• NCT number: NCT04742205
• Study type: Interventional
• Source: Kathmandu Medical College and Teaching Hospital
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: January 18, 2021
• Completion date: June 5, 2024