Skip to main content
OpenTrials
Completed

NCT Number: NCT04742205

ITCH Trial: 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

KMC Teaching Hospital, Kathmandu, Nepal

Kathmandu, Bagmati, 44811, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients presenting to the emergency department with symptom of hemorrhagic stroke within 24 hours from onset of symptom or last seen well.
  • Patient who had a follow up

Exclusion criteria

  • Glasgow coma scale <8 after resuscitation (as this can lead to biasness; requires surgery)
  • Contraindication to tranexamic acid,
  • Hemorrhagic stroke secondary to trauma,
  • Hemorrhage was caused by coagulopathy

Treatment and study plan

Tranexamic Acid 500 MG

Drug

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

Primary outcomes

  1. Radiological improvement (CT scan)

    Time frame: 48 hour

    Difference between hematoma volume from baseline and 48-hour post treatment scan

Secondary outcomes

  1. National Institutes of Health Stroke Scale

    Time frame: day 10

    Neurological impairment (score:0-42; 0:favourable outcome)

  2. Barthel index

    Time frame: days 10

    Disability (score:0-100; 100: independent)

  3. modified rankin scale

    Time frame: days 10 and 30, 90, 180

    dependency (score:0-5; 0: no symptom)

Other outcomes

  1. Death

    Time frame: day 180

    Number of death

Sponsors and collaborators

Lead sponsor

Kathmandu Medical College and Teaching Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 8, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.