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. 2025 Aug;20(7):891-897.
doi: 10.1177/17474930251342888. Epub 2025 May 12.

International Care Bundle Evaluation in Cerebral Hemorrhage Research (I-CATCHER): Study protocol for a multicenter, batched, parallel, cluster-randomized trial with a baseline period

Trine Apostolaki-Hansson  1   2 , Menglu Ouyang  3 , Dar Dowlatshahi  4 , Valeria Caso  5 , Alessandro Bufi  5 , Zhe Kang Law  6 , Laurent Billot  3 , Bo Norrving  2 , Craig S Anderson  3   7 , Teresa Ullberg  1   2
Affiliations

International Care Bundle Evaluation in Cerebral Hemorrhage Research (I-CATCHER): Study protocol for a multicenter, batched, parallel, cluster-randomized trial with a baseline period

Trine Apostolaki-Hansson et al. Int J Stroke. 2025 Aug.

Abstract

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.

Keywords: Intracerebral hemorrhage; blood pressure lowering; care bundle; cluster trial; implementation; outcome.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: B.N. reports honoraria from Symbec-ORION. T.U. reports speaker’s honoraria from Siemens Healthineers. C.S.A. reports grant support from the National Health and Medical Research Council (NHMRC) of Australia, the Medical Research Foundation of the UK, and is on the Advisory Board of AstraZeneca Australia. V.C. reports honoraria from BMS/Pfizer, Boehringer Ingelheim, EVER Pharma, Daichi Sankyo, and BAYER. D.D. reports honoraria from AstraZeneca Canada. Z.K.L. reports funding from Pro Active Synergy. The other authors declare no competing interests.

Figures

Graphical abstract
Graphical abstract
Figure 1.
Figure 1.
Parallel cluster-randomized design with a baseline period. Participating sites are launched in batches according to readiness. A group represents the number of sites in each region that are cluster-randomized to either the intervention or the control arm.
Figure 2.
Figure 2.
Study schema.
Figure 3.
Figure 3.
Logic model illustrating the implementation process and its relationship to clinical and implementation outcomes. aSupplemental Table 2 for more details on key implementation strategies. bSupplemental Table 1 for more details on implementation outcomes.
See this image and copyright information in PMC

References

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