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Could common drugs curb brain bleed aftermath?

NCT ID NCT06763055

Disease control Sponsor: The George Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial investigates whether two medications—colchicine (an anti-inflammatory) and deferoxamine (an iron chelator)—can prevent further brain injury after a hemorrhagic stroke. Up to 2,000 adults aged 18–80 with a spontaneous brain bleed will receive one of four treatments: standard care alone, colchicine for 30 days, deferoxamine for 2 days, or both drugs. The goal is to improve functional recovery and reduce disability at 6 months.

What this could mean

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

Active substance
Colchicine and Deferoxamine Mesylate
What this could lead to
If successful, this could provide a simple, widely available drug combination to reduce disability after a brain bleed.
What could go wrong
This is a large Phase 3 trial, but previous studies have not proven these drugs effective for this condition. Side effects from the drugs are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,000 people

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

Started

Feb 2025

Expected to finish

Jan 2028

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 80 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: 1. Age between 18 and 80 years old 2. Diagnosis of presumed spontaneous supratentorial intracerebral haemorrhage, confirmed by brain imaging 3. Presentation to hospital within 24 hours of symptom onset (or last seen well) 4. Hematoma volume ≥10 mL or any volume post-surgery 5. NIHSS score \>8 6. GCS ≥8 7. Provide written informed consent by patient (or approved surrogate) Exclusion Criteria: 1. Secondary cause of haemorrhage (e.g., structural abnormality such as arteriovenous malformation, cerebral aneurysm, tumour, trauma), or haemorrhagic transformation of acute ischaemic stroke 2. Isolate intraventricular haemorrhage 3. Chronic Kidney Disease 4. Very high likelihood of death within 7 days or poor adherence to study treatment or follow-up 5. Severe comorbid disease that will interfere with outcome assessments (e.g., cancer, chronic airflow disease, heart failure, significant disability) 6. Women who are pregnant or lactating Exclusion Criteria related to use of deferoxamine: 7. Previous chelation therapy or known hypersensitivity to deferoxamine products; 8. Severe iron deficiency anaemia (haemoglobin \<7 g/dL or requiring regular blood transfusions); 9. Taking iron supplements containing \>325 mg of ferrous iron; 10. Serum creatinine \>2 mg/dL; 11. Patients with known heart failure taking \>500 mg of vitamin C Exclusion criteria related to the use of colchicine: 12. Allergic to colchicine 13. Myelodysplastic hypoplasia, or liver or severe renal failure 14. Use of medication which may interact with colchicine (e.g., strong CYPsA4 inhibitors such as ketoconazole, strong P-glycoprotein inhibitors such as fluconazole)

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Conditions

The condition(s) this trial relates to.

intracerebral hemorrhage stroke disorder

As listed by the trial registrant

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

Acute intracerebral haemorrhage Acute stroke Intracerebral hemorrhage Spontaneous intracerebral hemorrhage Supratentorial intracerebral haemorrhage

How to take part

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

  1. The places running it

    2 sites in 2 countries. 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

  • Royal Prince Alfred Hospital

    NOT_YET_RECRUITING

    Sydney, New South Wales, 2050, Australia

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

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