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International Care Bundle Evaluation in Cerebral Hemorrhage Research (I-CATCHER): Study protocol for a multicenter,
Trine Apostolaki-Hansson1,2, Menglu Ouyang3, Dar Dowlatshahi4
1Department of Neurology, Skåne University Hospital, Malmö, Sweden.
Insights
This study investigates a care bundle for intracerebral hemorrhage (ICH) in high-income countries. The goal is to improve patient outcomes through a structured, evidence-based approach to acute stroke care.
Area of Science:
- Neurology
- Critical Care Medicine
- Public Health
Background:
- A care bundle approach has benefited intracerebral hemorrhage (ICH) patients in low- and middle-income countries.
- Uncertainty exists regarding the specific components and applicability of ICH care bundles in high-income countries.
- This study addresses the need for evidence on ICH care bundle implementation in high-income settings.
Purpose of the Study:
- To determine if implementing a comprehensive care bundle improves functional outcomes for patients with ICH in high-income countries.
- To evaluate the effectiveness and implementation of a multifaceted ICH care bundle.
Main Methods:
- An international, multicenter, cluster-randomized clinical trial involving adults with spontaneous ICH.
- The care bundle includes time- and target-based interventions: blood pressure lowering, fever/glucose management, anticoagulation reversal, and critical care/neurosurgery referrals.
- An embedded process evaluation will assess the effectiveness and implementation of the care bundle.
Main Results:
- The primary outcome is the utility-weighted modified Rankin scale (UW-mRS) score at 6 months.
- Secondary outcomes include mortality, functional status, and health-related quality of life.
- Implementation outcomes will assess adoption, fidelity, acceptability, sustainability, and integration of the care bundle.
Conclusions:
- The study aims to provide robust evidence for integrating a multifaceted ICH care bundle into acute stroke care globally.
- Findings will inform practice changes to improve the management of spontaneous intracerebral hemorrhage worldwide.
Rationale:
A care bundle approach to the management of spontaneous intracerebral hemorrhage (ICH) has been shown to benefit patients in low- and middle-income countries (LMIC), but uncertainty persists over the specific components and its applicability in high-income countries (HICs).
Aims:
An international collaborative initiative aimed at determining whether implementation of a care bundle improves functional outcome for patients with ICH in HIC.
Methods:
An international, multicenter, batched, parallel, cluster-randomized clinical trial focused on implementation and quality improvement for adults with spontaneous ICH ⩽ 24 h of symptom onset. The care bundle includes time- and target-based interventions: early intensive blood pressure lowering, hyperglycemia and pyrexia management, anticoagulation reversal, avoidance of do-not-resuscitate orders, repeat imaging, and referral pathways for intensive care and neurosurgery. An embedded process evaluation will assess the effectiveness and implementation of the care bundle.
Sample Size:
A total of 110 hospitals with 3500 ICH participants is estimated to provide 90% power (α = 0.05) to detect a plausible treatment effect of 0.20 improvement in utility-weighted modified Rankin scale (UW-mRS) scores.
Outcomes:
The primary outcome is UW-mRS at 6 months. Secondary outcomes include death, functional status, and health-related quality of life. Implementation outcomes include adoption, fidelity, acceptability, sustainability, and integration.
Discussion:
We aim to provide reliable evidence to accelerate practice change for integration of a multifaceted ICH care bundle as a critical component of acute stroke care worldwide.
Trial Registration:
Clinicaltrials.gov Identifier: NCT06429332.
