Comparing treatments for acute intracerebral hemorrhage to prevent secondary brain injury

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 trial is part of the ACT-GLOBAL platform and aims to evaluate the effectiveness of early pharmacological interventions in patients with acute spontaneous supratentorial intracerebral hemorrhage (ICH). It will enroll up to 2000 patients who will be randomized to receive standard care, deferoxamine, colchicine, or a combination of both. The study will follow participants for 6 months to assess outcomes related to secondary brain injury. Adaptive interim analyses will be conducted to determine if any of the treatments show superiority over the control group.

Why it matters

Who can join: the full rules

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)

Where it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting
• Royal Prince Alfred Hospital
  Sydney, New South Wales, Australia Not yet recruiting

Study contacts

• Study coordinator: Xiaoying Chen, PhD BPharm BMgt
• Email: xchen@georgeinstitute.org.au
• Phone: 4039448107

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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.