Using Tranexamic Acid to Treat Spontaneous Intracerebral Hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Government General Hospital
  Guntur, Andhra Pradesh, India Recruiting
• Lalitha Super Specialty Hospital
  Guntur, Andhra Pradesh, India Recruiting
• Dr Ramesh Cardiac and Multispecialty Hospital
  Guntur, Andhra Pradesh, India Recruiting
• Assam Medical College
  Dibrugarh, Assam, India Recruiting
• Guwahati Neurological Research Center
  Guwahati, Assam, India Recruiting
• Apollo Excelcare Hospitals
  Guwahati, Assam, India Recruiting

Study contacts

• Principal investigator: Jeyaraj D Pandian, MD DM — Christian Medical College and Hospital, Ludhiana, Punjab, India
• Study coordinator: Jeyaraj D Pandian, MD DM
• Email: jeyarajpandian@hotmail.com
• Phone: 9915784750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.