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Using Tranexamic Acid to Treat Spontaneous Intracerebral Hemorrhage

Indian Trial of Tranexamic Acid in Spontaneous Intracerebral Haemorrhage

Phase 4 Interventional Christian Medical College and Hospital, Ludhiana, India · NCT05836831

This study tests if giving Tranexamic Acid to adults with a type of stroke called spontaneous intracerebral hemorrhage can help them recover better when given soon after symptoms start.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment3400 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorChristian Medical College and Hospital, Ludhiana, India Academic / other
Locations48 sites (Guntur, Andhra Pradesh and 47 other locations)
Trial IDNCT05836831 on ClinicalTrials.gov

What this trial studies

This multicenter, pragmatic randomized clinical trial evaluates the effectiveness of Tranexamic Acid in improving outcomes for adult patients with spontaneous intracerebral hemorrhage. Participants who present within 4.5 hours of stroke symptom onset will be randomly assigned to receive either Tranexamic Acid or standard care. The treatment involves intravenous administration of Tranexamic Acid alongside intensive blood pressure management. The study aims to determine if early intervention with this medication can reduce complications and improve recovery outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who present with non-traumatic intracerebral hemorrhage within 4.5 hours of symptom onset.

Not a fit: Patients with hemorrhages due to anticoagulation, trauma, or known structural abnormalities, as well as those with severe comorbidities or low Glasgow coma scale scores, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery and reduce mortality rates in patients suffering from spontaneous intracerebral hemorrhage.

How similar studies have performed: Previous studies, such as the TICH 2 trial, have shown mixed results regarding the effectiveness of Tranexamic Acid in similar conditions, indicating the need for further investigation.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Adult patients aged more than 18 years, presenting with non- traumatic intracerebral haemorrhage within 4.5 hours of onset of stroke symptoms

Exclusion Criteria:

1. Patients with ICH secondary to anticoagulation, thrombolysis, or known underlying structural abnormality such as arteriovenous malformation, aneurysm, tumor, venous thrombosis or due to known hereditary coagulation disorders.
2. Contraindication to TXA.
3. Concurrent participation in another trial.
4. Pre-stroke life expectancy \<3 months (e.g. advanced metastatic cancer).
5. Glasgow coma scale (GCS) ⩽5.
6. ICH secondary to trauma.
7. Women of childbearing potential, pregnant, or breastfeeding at randomization.
8. Geographical or other factors that prohibit follow-upto 90 days.
9. Concurrent or planned treatment with any other hemostatic agents.
10. ICH volume \>60 mL as measured by ABC/2 method.

Where this trial is running

Guntur, Andhra Pradesh and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Intracerebral Hemorrhagic StrokeStrokeSpontaneous Intracerebral HaemorrhageTranexamic acid
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.