The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL

Launched by THE GEORGE INSTITUTE · Jan 1, 2025

Keywords

ClinConnect Summary

The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial is studying how to help patients who have experienced a specific type of brain bleed called spontaneous supratentorial intracerebral hemorrhage. Researchers want to see if two medications, deferoxamine and colchicine, can prevent further damage to the brain that can happen after the initial bleed. They will compare these medications, individually and together, against standard care to find out which treatment works best. Up to 2,000 patients aged 18 to 80 who have been hospitalized within 24 hours of their symptoms may be eligible to participate.

If you or a loved one qualify, you could be randomly assigned to one of four groups: receiving no additional treatment, deferoxamine only, colchicine only, or both medications together. The study will follow participants for six months to see how well they recover. It's important to know that certain health conditions or medications may exclude someone from participating, so discussing eligibility with a healthcare professional is crucial. Overall, this trial aims to improve outcomes for patients suffering from this serious condition.

Gender

ALL

Eligibility 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)