International Care Bundle Evaluation in Cerebral Hemorrhage Research
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 interventio
| Condition(s) | Intracerebral Hemorrhage, Intracerebral Haemorrhage, Intraventricular Hemorrhage, Stroke, Cerebrovascular Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Region Skane |
| Locations | Oklahoma City, Oklahoma, United States; Adelaide, Australia; Clayton, Australia; Sydney, Australia; Greater Sudbury, Ontario, Canada; Hamilton, Ontario, Canada (+48 more sites) |
| Start date | 2025-01-07 |
| NCT ID | NCT06429332 |
| Official listing | https://clinicaltrials.gov/study/NCT06429332 |