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

Apostolaki-Hansson, Trine LU orcid ; Ouyang, Menglu ; Dowlatshahi, Dar ; Caso, Valeria ; Bufi, Alessandro ; Law, Zhe Kang ; Billot, Laurent ; Norrving, Bo LU ; Anderson, Craig S. and Ullberg, Teresa LU (2025) In International Journal of Stroke 20(7).
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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
blood pressure lowering, care bundle, cluster trial, implementation, Intracerebral hemorrhage, outcome
in
International Journal of Stroke
volume
20
issue
7
article number
17474930251342888
publisher
Wiley-Blackwell
external identifiers
  • scopus:105009838325
  • pmid:40356012
ISSN
1747-4930
DOI
10.1177/17474930251342888
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2025 World Stroke Organization. This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
id
c7623ae6-7b3f-497d-ba8c-1250c4c80faf
date added to LUP
2026-01-19 14:46:41
date last changed
2026-01-20 03:00:03
@article{c7623ae6-7b3f-497d-ba8c-1250c4c80faf,
  abstract     = {{<p>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.</p>}},
  author       = {{Apostolaki-Hansson, Trine and Ouyang, Menglu and Dowlatshahi, Dar and Caso, Valeria and Bufi, Alessandro and Law, Zhe Kang and Billot, Laurent and Norrving, Bo and Anderson, Craig S. and Ullberg, Teresa}},
  issn         = {{1747-4930}},
  keywords     = {{blood pressure lowering; care bundle; cluster trial; implementation; Intracerebral hemorrhage; outcome}},
  language     = {{eng}},
  number       = {{7}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{International Journal of Stroke}},
  title        = {{International Care Bundle Evaluation in Cerebral Hemorrhage Research (I-CATCHER) : Study protocol for a multicenter, batched, parallel, cluster-randomized trial with a baseline period}},
  url          = {{http://dx.doi.org/10.1177/17474930251342888}},
  doi          = {{10.1177/17474930251342888}},
  volume       = {{20}},
  year         = {{2025}},
}