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

RecruitingPhase 3Ages 18 Years - 80 YearsAllThe George Institute
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In plain words

What the trial is, and whether it could suit you

This is a domain within the ACT-GLOBAL platform trial to compare the effectiveness of early and appropriate pharmacological interventions in acute intracerebral hemorrhage (ICH) to control secondary brain injury. Up to 2000 patients with presumed spontaneous supratentorial intracerebral hemorrhage (ICH) will be followed for 6 months (or death, if prior to 6 months). Adaptive interim analyses will be used, with statistical triggers to determine if any of the interventions are superior to control. The end of the trial is defined as the date that all participants have completed their 6-month assessment. A large amount of preclinical data indicates that the outcome from ICH is linked to the detrimental effects of breakdown substances from brain bleeds. However, there remains a lack of compelling evidence supporting the effectiveness of any pharmacological intervention that can mitigate the

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ10 mL or any volume post-surgery 5. NIHSS score \>8 6. GCS โ‰ฅ8 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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What it tests

  • Colchicine 0.5 mg
  • Deferoxamine Mesylate
  • Control (Standard treatment)
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Where

2 sites
Royal Prince Alfred Hospital
Sydney, Australia
West China Hospital of Sichuan University
Chengdu, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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