The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
Recruiting
Phase 3
Interventional Study
Intracerebral Hemorrhage
Spontaneous Intracerebral Hemorrhage
Supratentorial Intracerebral Haemorrhage
Acute Intracerebral Haemorrhage
Acute Stroke
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2,000 (estimated)
- Sponsor
- The George Institute · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 ≥10 mL or any volume post-surgery
5. N…
Contacts