Testing two drugs to limit further brain injury after brain bleeding
Tests colchicine and deferoxamine, alone or together, in adults with brain bleeding.
Plain-language title generated from the registry record
Registry title: The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
Key facts
- Where
- Sydney, AustraliaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06763055, who can take part
Where in Australia
- Royal Prince Alfred HospitalSydney, AustraliaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The George Institute
- Trial code
- NCT06763055
- Record updated
- 8 July 2026
- Original description
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).Read full original descriptionShow less
The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
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 secondary cerebral injury. The INTERACT domain aims to assess the effectiveness of intravenous deferoxamine and low-dose oral colchicine, both individually and in combination, to standard of care alone, on improving functional outcome in patients with spontaneous supratentorial ICH.
Those patients who meet eligibility criteria will be randomized to receive one of four interventions:
1. No deferoxamine mesylate and no colchicine (labeled as control) 2. Deferoxamine mesylate only: deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) post-randomization and continue for the following 2 consecutive days. 3. Colchicine only: 0.5mg of oral colchicine daily for 30 consecutive days. 4. Both deferoxamine mesylate and colchicine: deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) post-randomization and continue for the following 2 consecutive days; plus 0.5mg of oral colchicine daily for 30 consecutive days.
Inclusion: Age between 18 and 80 years old; Diagnosis of presumed spontaneous supratentorial intracerebral haemorrhage, confirmed by brain imaging; Presentation to hospital within 24 hours of symptom onset (or last seen well); Hematoma volume ≥10 mL or any volume post-surgery; NIHSS score >8; GCS ≥8; Provide written informed consent by patient (or approved surrogate).
Exclusion: Previous chelation therapy or known hypersensitivity to deferoxamine products; Use of medication which may interact with colchicine (e.g., strong CYPsA4 inhibitors such as ketoconazole, strong P-glycoprotein inhibitors such as fluconazole); Secondary cause of haemorrhage (e.g., structural abnormality such as arteriovenous malformation, cerebral aneurysm, tumour, trauma), or haemorrhagic transformation of acute ischaemic stroke; Isolate intraventricular haemorrhage; Chronic Kidney Disease; Severe comorbid disease that will interfere with outcome assessments (e.g., cancer, chronic airflow disease, heart failure, significant disability); Patients with known heart failure taking >500 mg of vitamin C; Allergic to colchicine; Myelodysplastic hypoplasia, or liver or severe renal failure; Severe iron deficiency anaemia (haemoglobin <7 g/dL or requiring regular blood transfusions); Serum creatinine >2 mg/dL; Very high likelihood of death within 7 days or poor adherence to study treatment or follow-up; Women who are pregnant or lactating; Taking iron supplements containing >325 mg of ferrous iron.