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

Last updated: March 18, 2025
Sponsor: Kathmandu Medical College and Teaching Hospital
Overall Status: Completed

Phase

2/3

Condition

Hemorrhage

Stroke

Brain Injury

Treatment

Tranexamic Acid 500 MG

Clinical Study ID

NCT04742205
KathmanduMCTH
  • Ages 20-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. All patients presenting to the emergency department with symptom of hemorrhagicstroke within 24 hours from onset of symptom or last seen well.

  2. Patient who had a follow up

Exclusion

Exclusion Criteria:

  1. Glasgow coma scale <8 after resuscitation (as this can lead to biasness; requiressurgery)

  2. Contraindication to tranexamic acid,

  3. Hemorrhagic stroke secondary to trauma,

  4. Hemorrhage was caused by coagulopathy

Study Design

Total Participants: 154
Treatment Group(s): 1
Primary Treatment: Tranexamic Acid 500 MG
Phase: 2/3
Study Start date:
February 08, 2021
Estimated Completion Date:
June 04, 2024

Study 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.

Connect with a study center

  • KMC Teaching Hospital, Kathmandu, Nepal

    Kathmandu, Bagmati 44811
    Nepal

    Site Not Available

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