Condition: Intracerebral Hemorrhage · Spontaneous Intracerebral Hemorrhage · Supratentorial Intracerebral Haemorrhage · Sponsor: The George Institute
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-randomiz…
This description comes directly from the study's public registry record.
Xiaoying Chen, PhD BPharm BMgt · 4039448107 · xchen@georgeinstitute.org.au
Craig Anderson, MD · 4039448107 · canderson@georgeinstitute.org.au
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| Royal Prince Alfred Hospital | Sydney, New South Wales, Australia | Not Yet Recruiting |
| West China Hospital of Sichuan University | Chengdu, Sichuan, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06763055