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Can a common drug stop brain bleeds? major trial launches

NCT ID NCT05836831

Disease control Sponsor: Christian Medical College and Hospital, Ludhiana, India Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large, phase 4 trial tests whether tranexamic acid, a drug that helps blood clot, can improve outcomes for people with a bleeding stroke. About 3400 adults will receive either the drug or standard care within 4.5 hours of symptoms. The main goal is to see if it reduces deaths at 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tranexamic acid
What this could lead to
If it works, this could provide a simple, widely available treatment to reduce bleeding and improve survival after a hemorrhagic stroke.
What could go wrong
This is a large trial, but earlier studies on tranexamic acid for brain bleeds have shown mixed results. The drug may not meaningfully improve outcomes and could increase the risk of blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 3,400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

Hemorrhagic Stroke intracerebral hemorrhage stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracerebral hemorrhagic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASTER MIMS Hospital

    RECRUITING

    Calicut, Kerala, 673016, India

  • All India Institute of Medical Sciences

    RECRUITING

    Bilāspur, Himachal Pradesh, 174001, India

  • All India Institute of Medical Sciences

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110029, India

  • All India Institute of Medical Sciences

    RECRUITING

    Bhubaneswar, Odisha, 751019, India

  • Amrita Institute for Medical Sciences and Research Center

    RECRUITING

    Kochi, Kerala, 682041, India

  • Apollo Excelcare Hospitals

    RECRUITING

    Guwahati, Assam, 781033, India

  • Artemis Hospital

    RECRUITING

    Gurgaon, Haryana, 122001, India

  • Assam Medical College

    RECRUITING

    Dibrugarh, Assam, 786001, India

  • Atal Institute of Medical Super Specilities, (AIMSS) Chamiana

    RECRUITING

    Shimla, Himachal Pradesh, 171001, India

  • Baby Memorial Hospital

    RECRUITING

    Calicut, Kerala, 673004, India

  • Bangur Institute of Neurosciences

    RECRUITING

    Kolkata, West Bengal, 700020, India

  • Baptist Christian Hospital

    RECRUITING

    Tezpur, Assam, 784001, India

  • Bharati Vidyapeeth DTU Medical College

    RECRUITING

    Pune, Maharashtra, 411043, India

  • CARE Hospitals

    RECRUITING

    Hyderabad, Telangana, Hyderabad, India

  • Christian Medical College Vellore

    RECRUITING

    Vellore, Tamil Nadu, 632517, India

  • Christian Medical College and Hospital, Ludhiana, Punjab

    RECRUITING

    Ludhiana, Punjab, 141008, India

  • Dr Ramesh Cardiac and Multispecialty Hospital

    RECRUITING

    Guntur, Andhra Pradesh, 522004, India

  • Dr. Kamakshi Memorial Hospital

    RECRUITING

    Chennai, Tamil Nadu, 600100, India

  • Fortis Escorts Hospital

    RECRUITING

    Jaipur, Rajasthan, 302017, India

  • Fortis Hospital Mulund

    RECRUITING

    Mumbai, Maharashtra, 400078, India

  • Government General Hospital

    RECRUITING

    Guntur, Andhra Pradesh, 522001, India

  • Government Medical College Trivandrum

    RECRUITING

    Thiruvananthapuram, Kerala, 695011, India

  • Guru Gobind Singh Medical College and Hospital

    RECRUITING

    Farīdkot, Punjab, 151203, India

  • Guwahati Neurological Research Center

    RECRUITING

    Guwahati, Assam, 781006, India

  • Holy Spirit Hospital

    RECRUITING

    Mumbai, Maharashtra, 400093, India

  • Institute of Human Behaviour and Allied Sciences

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110095, India

  • Institute of Medical Sciences of the Banaras Hindu University (BHU)

    RECRUITING

    Varanasi, Uttar Pradesh, 221005, India

  • Institute of Neurosciences

    RECRUITING

    Kolkata, West Bengal, 700017, India

  • Jawaharlal Institute of Postgraduate Medical Education and Research

    RECRUITING

    Puducherry, Tamil Nadu, 605006, India

  • KG Hospital and Post Graduate Medical Institute Coimbatore

    RECRUITING

    Coimbatore, Tamil Nadu, 641018, India

  • KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre

    RECRUITING

    Belagavi, Karnataka, 590010, India

  • Kasturba Medical College Manipal

    RECRUITING

    Manipal, Karnataka, 576104, India

  • King George's Medical University

    RECRUITING

    Lucknow, Uttar Pradesh, 226003, India

  • Lalitha Super Specialty Hospital

    RECRUITING

    Guntur, Andhra Pradesh, 522001, India

  • Manipal Hospital

    NOT_YET_RECRUITING

    Panjim, Goa, 403004, India

  • Manipal Hospital

    NOT_YET_RECRUITING

    Bangalore, Karnataka, 560017, India

  • National Institute of Mental Health and Neuro-Sciences

    NOT_YET_RECRUITING

    Bangalore, Karnataka, 560029, India

  • PBM Hospital

    RECRUITING

    Bikaner, Rajasthan, 334001, India

  • Postgraduate Institute for Medical Education and Research

    RECRUITING

    Chandigarh, 160012, India

  • Ruby Hall Clinic

    RECRUITING

    Pune, Maharashtra, 411001, India

  • Santokba Durlabhji Memorial Hospital

    RECRUITING

    Jaipur, Rajasthan, 302015, India

  • Shree Krishna Hospital Pramukhswami Medical College

    RECRUITING

    Anand, Gujarat, 388325, India

  • Sparsh Superspeciality Hospital

    RECRUITING

    Bangalore, Karnataka, 560022, India

  • Sree Chitra Tirunal Institute for Medical Sciences and Technology

    RECRUITING

    Thiruvananthapuram, Kerala, 695011, India

  • St Stephen's Hospital

    RECRUITING

    Delhi, 110054, India

  • Tezpur Medical College and Hospital

    RECRUITING

    Tezpur, Assam, 784153, India

  • The Calcutta Medical Research Center

    RECRUITING

    Kolkata, West Bengal, 700027, India

  • Tirunelveli Medical College

    RECRUITING

    Tirunelveli, Tamil Nadu, 627011, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.