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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Australia
Royal Prince Alfred Hospital
NOT_YET_RECRUITING
Sydney
China
West China Hospital of Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Xiaoying Chen, PhD BPharm BMgt
xchen@georgeinstitute.org.au
4039448107
Backup
Craig Anderson, MD
canderson@georgeinstitute.org.au
4039448107
Time Frame
Start Date: 2025-02-27
Estimated Completion Date: 2028-01
Participants
Target number of participants: 2000
Treatments
Placebo_comparator: No deferoxamine mesylate, No colchicine (control)
The group will not receive deferoxamine mesylate or colchicine
Active_comparator: Deferoxamine mesylate only
The intervention group will receive deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) of randomization and continued for 2 consecutive days.
Active_comparator: Colchicine only
The intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Active_comparator: Both deferoxamine mesylate and colchicine
The intervention group will receive deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) and continued for 2 consecutive days; plus 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.
Related Therapeutic Areas
Sponsors
Leads: The George Institute
Collaborators: University of Calgary

This content was sourced from clinicaltrials.gov