International Care Bundle Evaluation in Cerebral Hemorrhage Research (I-CATCHER)

May 20, 2026 updated by: Region Skane

International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Spontaneous intracerebral hemorrhage (ICH) accounts for 10 to 15% of all strokes in high-income countries (HIC), and nearly twice this number in low-income to upper-middle-income countries (LMIC) (29.5%). It is the most devastating type of stroke given the high one-month case fatality of approximately 30-40%, and only 12-39% suffer persistent disability.

Despite several advances in the management of acute ischemic stroke supported by numerous randomized controlled trials (RCT), progress in establishing novel interventions to improve outcomes for ICH has been slow. Still today, the diagnosis of ICH evokes pessimism among treating physicians, and patients may be withheld guideline adherent treatment for this reason. This nihilistic approach is presumably due to an over-estimation of poor outcome, often influenced by the neurologically devastating features commonly present at ICH admission. Additionally, the scarcity of RCTs providing strong evidence for treatment recommendations may contribute to a more reluctant approach in the acute setting of ICH, particularly when presenting with debilitating symptoms.

The third INTEnsive care bundle with BP reduction in acute cerebral hemorrhage trial (INTERACT3) was recently published in 2023. This trial employed a stepped wedge cluster RCT design to evaluate the implementation of a Care Bundle protocol. This comprehensive protocol included early intensive BP lowering (EIBPL), management of pyrexia and hyperglycemia, and the early reversal of OAC treatment. The design of this trial drew inspiration from a post-hoc analysis of the INTERACT2 study that showed that the scoring of abnormal baseline variables, interventions included in the future INTERACT3 Care Bundle, independently predicted a poor functional outcome following ICH. The implementation of the time sensitive bundle of care in INTERACT3 resulted in an improved functional outcome at 6 months following ICH. However, as the trial included patients predominantly from LMIC, further studies are warranted to determine if these results are applicable to HIC with a more applicable Care Bundle for these populations. An earlier intervention study from the United Kingdom, published in 2019, studied a similar 'quality improvement' acute Care Bundle. This Care Bundle aimed to improve the speed of treatment delivery, access to acute care, and decrease case fatality following ICH. Despite certain limitations, including a non-randomized design, this study demonstrated significantly lower mortality rates in patients receiving the Care Bundle versus the pre-implementation standard of care.

I-CATCHER is an international, multicenter, batched, parallel, cluster, randomized clinical trial (RCT) to assess a multifaceted package of protocols in a broad range of patients with acute ICH. In each batch, hospitals will be randomized into two groups according to the timing of the intervention (Care Bundle) over 3 phases (phase 1: usual care, phase 2: randomized evaluation - to intervention or usual care, phase 3: post-implementation follow-up - all hospitals implement the intervention). This design will capture consecutive patients with ICH and allow continued intervention in perpetuity as more hospitals join. Compared to a conventional stepped-wedge cluster RCT, the intervention effect in this design is less likely to be confounded by background temporal trends as only baseline and parallel comparison data (first 2 periods in bold black frame) are used to determine the effectiveness of the Care Bundle. All hospitals will be exposed to the Care Bundle which allows assessment of sustainability and integration of the intervention into routine practice. Each batch period is 18 months (6 months per phase); whole study will be rolled out in 2.5 years.

This design involves implementation of an intervention package applied to all patients with ICH as part of routine care. Patients are only excluded if they refuse to have details of their management included and/or participate in follow-up procedures.

Study site inclusion criteria: Organized systems of acute stroke care; no established comprehensive protocols for the management of ICH; suitable location, infrastructure and willingness to participate in clinical research; suitable numbers of ICH patients (at least 30 per year).

Patient inclusion criteria: Adults (≥18 years) with spontaneous ICH confirmed by imaging and admitted hospital within 24 hours of the onset of symptoms.

Study Type

Interventional

Enrollment (Estimated)

3500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
      • Clayton, Australia, 3168
      • Sydney, Australia, NSW 2000
        • Not yet recruiting
        • The George Institute for Global Health
        • Contact:
        • Principal Investigator:
          • Menglu Ouyang, PhD, MPH
  • Canada
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Recruiting
        • Health Sciences North/Health Sciences North Research Institute
        • Contact:
      • Hamilton, Ontario, Canada, L8L 2X2
        • Recruiting
        • Hamilton General Hospital
        • Contact:
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Recruiting
        • Ottawa Hospital Research Institute
        • Contact:
          • Dar Dowlatshahi, MD PhD FRCPC
          • Phone Number: +1 613-761-4709
          • Email: ddowlat@toh.ca
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong University Hospital
        • Contact:
          • Kay Cheong Teo, MD
          • Phone Number: (+852) 2255 3749
          • Email: kcteo@hku.hk
  • Iceland
      • Reykjavik, Iceland, 105
        • Recruiting
        • Landspitali University Hospital
        • Contact:
          • Björn Logi Þórarinsson, MD MSc FESO
          • Phone Number: +354 8253850
  • Italy
      • Avezzano, Italy, 67051
        • Recruiting
        • Avezzano Ospedale SS. Filippo e Nicola
        • Contact:
        • Principal Investigator:
          • Raffaele Ornello, MD
      • Città di Castello, Italy, 06012
        • Recruiting
        • Citta di Castello Ospedale Città di Castello
        • Contact:
        • Contact:
          • Phone Number: +39 075 9270801
      • Gubbio, Italy, Italy
        • Recruiting
        • Gubbio Ospedale di Gubbio e Gualdo Tadino
        • Contact:
      • Perugia, Italy, 06129
        • Recruiting
        • Azienda Ospedaliera Santa Maria della Misericordia Perugia
        • Contact:
        • Sub-Investigator:
          • Valeria Caso
      • Roma, Italy, 00136
  • Malaysia
      • Kuala Lumpur, Malaysia, 56000
        • Recruiting
        • National University of Malaysia Hospital
        • Contact:
      • Serdang, Malaysia, 43400
        • Recruiting
        • Universiti Putra Malaysia Hospital
        • Contact:
  • Sweden
      • Eksjö, Sweden, 575 81
        • Recruiting
        • Höglandssjukhuset i Eksjö
        • Contact:
      • Gothenburg, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset
        • Contact:
      • Gothenburg, Sweden, 41685
      • Helsingborg, Sweden
        • Recruiting
        • Helsingborgs Lasarett
        • Contact:
        • Principal Investigator:
          • Gustaf Westerberg, MD
      • Huddinge, Sweden
      • Hässleholm, Sweden
        • Recruiting
        • Hässleholms Sjukhus
        • Principal Investigator:
          • Magnus Esbjörnsson, MD
        • Contact:
      • Jönköping, Sweden, 551 85
        • Recruiting
        • Länssjukhuset Ryhov
        • Contact:
      • Kalmar, Sweden, 391 85
      • Karlskrona, Sweden
      • Karlskrona, Sweden, 371 41
      • Karlstad, Sweden, 651 85
      • Kristianstad, Sweden
        • Recruiting
        • Centralsjukhuset Kristianstad
        • Contact:
        • Principal Investigator:
          • Jon Paradis
        • Principal Investigator:
          • Jon Eliasson, MD PhD
      • Kungälv, Sweden, 442 83
      • Köping, Sweden, 731 81
      • Linköping, Sweden, 581 85
      • Ljungby, Sweden, 341 35
      • Lund, Sweden
        • Recruiting
        • Skane University Hospital Lund
        • Contact:
        • Principal Investigator:
          • Gunnar Andsberg, MD PhD
      • Lund, Sweden
        • Recruiting
        • Skåne University Hospital Lund Neurosurgery dept
        • Contact:
        • Principal Investigator:
          • Nathanael Göransson, MD
      • Malmö, Sweden, 20502
        • Recruiting
        • Region Skåne, Skåne University Hospital in Malmö, Department of Neurology
        • Contact:
        • Principal Investigator:
          • Trine Apostolaki-Hansson, MD PhD
        • Principal Investigator:
          • Fredrik Buchwald, MD PhD
      • Mölndal, Sweden, 431 80
      • Oskarshamn, Sweden, 572 28
      • Skövde, Sweden, 541 85
      • Stockholm, Sweden, 118 83
      • Stockholm, Sweden, 171 76
      • Stockholm, Sweden, 182 88
      • Stockholm, Sweden, 112 81
      • Sundsvall, Sweden
        • Recruiting
        • Länssjukhuset Sundsvall
        • Contact:
        • Principal Investigator:
          • Vincy Eklöf, MD PhD
      • Trollhättan, Sweden, 461 85
        • Recruiting
        • Norra Älvsborgs Länssjukhus
        • Contact:
      • Umeå, Sweden
        • Recruiting
        • Norrlands Universitetssjukhus
        • Contact:
        • Principal Investigator:
          • Johan Birnefeld, MD
        • Principal Investigator:
          • Jonatan Salzer, MD PhD
      • Uppsala, Sweden, 751 85
      • Uppsala, Sweden, 75185
        • Recruiting
        • Akademiska Sjukhuset Uppsal
        • Contact:
      • Varberg, Sweden, 43237
      • Vaxjo, Sweden
        • Recruiting
        • Centrallasarettet Växjö
        • Contact:
        • Principal Investigator:
          • Johan Weber, MD
        • Principal Investigator:
          • Johan Larsson, MD
      • Värnamo, Sweden, 331 85
        • Recruiting
        • Värnamo sjukhus
        • Contact:
      • Västerås, Sweden, 721 89
      • Ystad, Sweden
        • Recruiting
        • Ystads lasarett
        • Contact:
        • Principal Investigator:
          • Martin Ekdahl, MD
      • Örebro, Sweden, 701 85
      • Östersund, Sweden
        • Recruiting
        • Östersunds Lasarett
        • Contact:
        • Principal Investigator:
          • Joachim Ögren, MD PhD
  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73126-0901
        • Recruiting
        • The University of Oklahoma Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
A range of implementation methods will be used to introduce an active Care Bundle with time- and target-based metrics that involve the rapid correction of abnormal physiological variables over days or hospital discharge (or death, if sooner) and referral pathways
Other: Do-not-resuscitate (DNR) or withdrawal of care
Refrain from the use of DNR or withdrawal of care orders for 48 hours
Other: Referral to Intensive Care
Immediate (<30 min) referral to intensive care if airway, breathing and/or circulation are compromized
Other: Referral to Neurosurgery

Immediate (<30 min) referral to neurosurgery if any of the following criteria are fulfilled:

  • Large and/or rapidly evolving supratentorial ICH (>20 ml volume)
  • Any intraventricular extension
  • Posterior fossa bleed, irrespective of volume
  • Suspicion of a vascular malformation, independent of volume or location
  • Reduction in reaction to sensory stimulation or drowsiness
Diagnostic test: Repeat brain imaging
Repeat 6-12-hour brain imaging with the physicians choice of modality, preferably computed tomography (CT), if clinical deterioration or the patient received OAC reversal treatment
Other: Reversal of Oral anticoagulation within 30 minutes
In situations of either an elevated INR with the use of warfarin - treatment with either 3- or 4-factor prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP) within 30 minutes of ICH diagnosis on NCCT to reach and maintain an INR target <1.3; or where there has been recent use (<48 hours) of a direct oral anticoagulant (DOAC), use of an appropriate reversal agent within 30 minutes, where available, and according to local approvals.
Other Names:
  • OAC reversal
Other: Early intensive blood pressure lowering
A systolic blood pressure (BP) target of 130-140 mmHg within 30 minutes of ICH diagnosis on NCCT is strived for, and to maintain this BP level for the first 7 days (for patients presenting with blood pressure <200 mmHg). If blood pressure ≥200 and <220, a target BP of 160 mmHg should be targeted at 30 minutes, and 130-140 mmHg should be achieved in 60 minutes. If BP ≥220, target BP of 160 mmHg and should be achieved in 60 minutes.
Other: Treatment of pyrexia
To achieve a body temperature target <37.5 °C within the first 24h following ICH diagnosis on NCCT
Other: Hyperglycemia treatment
To maintain a blood glucose level 7-10 mmol/L within the first 24h following ICH diagnosis on NCCT
Placebo Comparator: Usual care
For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.
Other: Standard care
For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score
Time Frame: 180±30 days
The modified Rankin Scale (mRS) is an efficient, reliable, and simple functional outcome measure widely used as a primary endpoint in clinical trials for acute stroke. However, being an ordered categorical scale, it may not reflect potentially unequal differences in perceived quality of life associated with certain 1-point shifts vs others. Utility-weighted mRS is a score that weighs the mRS against a health utility scale, which defined as the desirability of a specific health outcome, facilitates comparisons of health-related quality of life across an array of clinical settings. Utility weights, as referred to hereafter, reflect the spectrum between perfect health (a score of 1) and outcomes worse than death (where death is a score of 0 and negative values indicate an outcome worse than death). The primary outcome is UW-mRS at 3 months and will be analyzed by means of a linear regression, with mRS as a dependent variable with 7 levels (0 [no residual symptom] to 6 [death]).
180±30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ordinal shift analysis of mRS
Time Frame: 180 days±30 days
The assessment of shifts in the distribution of mRS scores through the evaluation of scores in ordinal groups
180 days±30 days
Assessment of health-related quality of life (HRQoL)
Time Frame: 180 days±30 days
This will be assessed using the EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D). The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
180 days±30 days
Poor outcome defined as mRS 3-6
Time Frame: 180 days±30 days
Binary secondary outcomes will be analyzed by means of standard GEE or random-effects regression with a logistic link and/or time-to-event type endpoints using the Cox model with a sandwich formula or a frailty model.
180 days±30 days
Separate outcomes for death and disability
Time Frame: 180 days±30 days
Binary secondary outcomes will be analyzed by means of standard GEE or random-effects regression with a logistic link and/or time-to-event type endpoints using the Cox model with a sandwich formula or a frailty model.
180 days±30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

Ottawa Hospital Research Institute
The George Institute for Global Health, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-02523-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Do-not-resuscitate (DNR) or withdrawal of care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe