Comparing treatments for acute intracerebral hemorrhage to prevent secondary brain injury
The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
This study is testing if giving certain medications early can help prevent further brain damage in people with a type of bleeding in the brain.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The George Institute Academic / other |
| Locations | 2 sites (Sydney, New South Wales and 1 other locations) |
| Trial ID | NCT06763055 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with confirmed spontaneous supratentorial intracerebral hemorrhage who present to the hospital within 24 hours of symptom onset.
Not a fit: Patients with secondary causes of hemorrhage, chronic kidney disease, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options that reduce brain damage and enhance recovery for patients with acute intracerebral hemorrhage.
How similar studies have performed: Previous studies have shown promise in using pharmacological interventions to mitigate secondary injury in ICH, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Sydney, New South Wales and 1 other locations
- Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Xiaoying Chen, PhD BPharm BMgt
- Email: xchen@georgeinstitute.org.au
- Phone: 4039448107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.