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

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.

Conditions

• Intracerebral Hemorrhage
• Spontaneous Intracerebral Hemorrhage
• Supratentorial Intracerebral Haemorrhage
• Acute Intracerebral Haemorrhage
• Acute Stroke

Interventions

DRUG

Colchicine 0.5 mg

The intervention group will receive 0.5mg of oral colchicine daily as soon as possible after randomization, to continue for 30 days.

DRUG

Deferoxamine Mesylate

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

OTHER

Control (Standard treatment)

The group will not receive deferoxamine mesylate or colchicine

Sponsors & Collaborators

• University of Calgary

  collaborator OTHER

• The George Institute

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-27

Primary Completion

2028-01-31

Completion

2028-01-31

Countries

• Australia
• China

Study Locations