NCT06429332 International Care Bundle Evaluation in Cerebral Hemorrhage Research
| NCT ID | NCT06429332 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Region Skane |
| Condition | Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,500 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,500 participants in total. It began in 2025-01-07 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. Despite this, intensive care and neurosurgical interventions are uncommon. A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering, as well as the treatment of pyrexia and elevated blood glucose levels. The I-CATCHER team is now planning to conduct a similar study in Sweden and Australia, as well as in other high-income countries. The study has a clear focus on implementation, aiming to improve treatment and prognosis for patients with ICH within a few years. The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.
Eligibility Criteria
Inclusion Criteria: * Adults (age ≥18 years) * Non-contrast computerized tomography (NCCT) imaging-verified diagnosis of spontaneous intracerebral haemorrhage * ≤24 hours from symptom onset or presumed symptom onset (last seen well) Exclusion Criteria: * Previous care limitation * End-stage comorbidity with short life-expectancy (\<6 m; e.g. terminal cancer) * ICH caused by brain tumor or cerebral venous thrombosis * Clinical signs of brain herniation at first presentation (unresponsive patient with bilaterally fixed, maximally dilated pupils) * Pregnant women beyond 22 weeks gestation may only be included after thorough discussion with an obstetrician to determine risks vs benefit.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06429332 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06429332 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06429332 currently recruiting?
Yes, NCT06429332 is actively recruiting participants. Contact the research team at i-catcher@med.lu.se for enrollment information.
Where is the NCT06429332 trial being conducted?
This trial is being conducted at Oklahoma City, United States, Adelaide, Australia, Clayton, Australia, Sydney, Australia and 11 additional locations.
Who is sponsoring the NCT06429332 clinical trial?
NCT06429332 is sponsored by Region Skane. The trial plans to enroll 3,500 participants.