International Care Bundle Evaluation in Cerebral Hemorrhage Research
NCT ID: NCT06429332
Last Updated: 2026-02-09
Study Results
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Basic Information
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RECRUITING
PHASE4
3500 participants
INTERVENTIONAL
2025-01-07
2027-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
In each batch, hospitals are randomized into two groups according to the timing of the intervention (Care Bundle) over 3 phases (usual care, randomized evaluation, post-implementation follow-up):
Phase 1 - baseline routine data collection, training and formative study (assess context and local resources, support adjustment of the protocol into local pathways) Phase 2 - start intervention implementation in the intervention group, data collection for comparison with usual care in the control group Phase 3 - all hospitals implement the intervention, data collection for quality improvement, assess sustainability and integration
TREATMENT
SINGLE
Study Groups
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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
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.
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.
Treatment of pyrexia
To achieve a body temperature target \<37.5 °C within the first 24h following ICH diagnosis on NCCT
Hyperglycemia treatment
To maintain a blood glucose level 7-10 mmol/L within the first 24h following ICH diagnosis on NCCT
Do-not-resuscitate (DNR) or withdrawal of care
Refrain from the use of DNR or withdrawal of care orders for 48 hours
Referral to Intensive Care
Immediate (\<30 min) referral to intensive care if airway, breathing and/or circulation are compromized
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
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
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.
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.
Interventions
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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.
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.
Treatment of pyrexia
To achieve a body temperature target \<37.5 °C within the first 24h following ICH diagnosis on NCCT
Hyperglycemia treatment
To maintain a blood glucose level 7-10 mmol/L within the first 24h following ICH diagnosis on NCCT
Do-not-resuscitate (DNR) or withdrawal of care
Refrain from the use of DNR or withdrawal of care orders for 48 hours
Referral to Intensive Care
Immediate (\<30 min) referral to intensive care if airway, breathing and/or circulation are compromized
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
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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The George Institute for Global Health, Australia
OTHER
Ottawa Hospital Research Institute
OTHER
Region Skane
OTHER
Responsible Party
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Locations
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The University of Oklahoma Health
Oklahoma City, Oklahoma, United States
Royal Adelaide Hospital
Adelaide, , Australia
Monash Medical Centre
Clayton, , Australia
The George Institute for Global Health
Sydney, , Australia
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Hong Kong University Hospital
Hong Kong, , Hong Kong
Landspitali University Hospital
Reykjavik, , Iceland
Avezzano Ospedale SS. Filippo e Nicola
Avezzano, , Italy
Citta di Castello Ospedale Città di Castello
Città di Castello, , Italy
Gubbio Ospedale di Gubbio e Gualdo Tadino
Gubbio, , Italy
Azienda Ospedaliera Santa Maria della Misericordia Perugia
Perugia, , Italy
Roma Policlinico Gemelli
Roma, , Italy
National University of Malaysia Hospital
Kuala Lumpur, , Malaysia
Universiti Putra Malaysia Hospital
Serdang, , Malaysia
Höglandssjukhuset i Eksjö
Eksjö, , Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Östra Sjukhuset
Gothenburg, , Sweden
Hässleholms Sjukhus
Hässleholm, , Sweden
Helsingborgs Lasarett
Helsingborg, , Sweden
Karolinska Universitetssjukhuset Huddinge
Huddinge, , Sweden
Länssjukhuset Ryhov
Jönköping, , Sweden
Länssjukhuset Kalmar
Kalmar, , Sweden
Blekingesjukhuset Karlskrona
Karlskrona, , Sweden
Blekingesjukhuset
Karlskrona, , Sweden
Centralsjukhuset Karlstad
Karlstad, , Sweden
Västmanlands sjukhus Köping
Köping, , Sweden
Centralsjukhuset Kristianstad
Kristianstad, , Sweden
Kungälvs sjukhus
Kungälv, , Sweden
Univeristetssjukhuset Linköping
Linköping, , Sweden
Ljungby Lasarett
Ljungby, , Sweden
Skåne University Hospital Lund Neurosurgery dept
Lund, , Sweden
Skåne University Hospital Lund
Lund, , Sweden
Region Skåne, Skåne University Hospital in Malmö, Department of Neurology
Malmo, , Sweden
Mölndals Sjukhus
Mölndal, , Sweden
Oskarshamn Sjukhus
Oskarshamn, , Sweden
Universitetssjukhuset Örebro
Örebro, , Sweden
Östersunds Lasarett
Östersund, , Sweden
Skaraborgs Sjukhus Skövde
Skövde, , Sweden
Capio St Görans Sjukhus
Stockholm, , Sweden
Södersjukhuset
Stockholm, , Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
Danderyds sjukhus
Stockholm, , Sweden
Länssjukhuset Sundsvall
Sundsvall, , Sweden
Norra Älvsborgs Länssjukhus
Trollhättan, , Sweden
Norrlands Universitetssjukhus
Umeå, , Sweden
Lasarettet i Enköping
Uppsala, , Sweden
Akademiska Sjukhuset Uppsal
Uppsala, , Sweden
Hallands sjukhus Varberg
Varberg, , Sweden
Centrallasarettet Växjö
Vaxjo, , Sweden
Värnamo sjukhus
Värnamo, , Sweden
Västerås
Västerås, , Sweden
Ystads lasarett
Ystad, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Björn Logi Þórarinsson, MD MSc FESO
Role: primary
Role: backup
References
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Qureshi AI, Tuhrim S, Broderick JP, Batjer HH, Hondo H, Hanley DF. Spontaneous intracerebral hemorrhage. N Engl J Med. 2001 May 10;344(19):1450-60. doi: 10.1056/NEJM200105103441907. No abstract available.
Draeger J, Wiezorrek R, Hock B, Gerhard E, Klemm M. [Physical technical calibration of a new self-tonometer]. Ophthalmologe. 1993 Feb;90(1):51-3. German.
van Asch CJ, Luitse MJ, Rinkel GJ, van der Tweel I, Algra A, Klijn CJ. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. 2010 Feb;9(2):167-76. doi: 10.1016/S1474-4422(09)70340-0. Epub 2010 Jan 5.
Parry-Jones AR, Sammut-Powell C, Paroutoglou K, Birleson E, Rowland J, Lee S, Cecchini L, Massyn M, Emsley R, Bray B, Patel H. An Intracerebral Hemorrhage Care Bundle Is Associated with Lower Case Fatality. Ann Neurol. 2019 Oct;86(4):495-503. doi: 10.1002/ana.25546. Epub 2019 Aug 16.
Hemphill JC 3rd, Newman J, Zhao S, Johnston SC. Hospital usage of early do-not-resuscitate orders and outcome after intracerebral hemorrhage. Stroke. 2004 May;35(5):1130-4. doi: 10.1161/01.STR.0000125858.71051.ca. Epub 2004 Mar 25.
Becker KJ, Baxter AB, Cohen WA, Bybee HM, Tirschwell DL, Newell DW, Winn HR, Longstreth WT Jr. Withdrawal of support in intracerebral hemorrhage may lead to self-fulfilling prophecies. Neurology. 2001 Mar 27;56(6):766-72. doi: 10.1212/wnl.56.6.766.
Zahuranec DB, Brown DL, Lisabeth LD, Gonzales NR, Longwell PJ, Smith MA, Garcia NM, Morgenstern LB. Early care limitations independently predict mortality after intracerebral hemorrhage. Neurology. 2007 May 15;68(20):1651-7. doi: 10.1212/01.wnl.0000261906.93238.72.
Logan JS, Bharucha H, Sloan JM. Mesotheliomas all: long before their time. Ulster Med J. 1996 May;65(1):1-2. No abstract available.
Apostolaki-Hansson T, Ouyang M, Dowlatshahi D, Caso V, Bufi A, Law ZK, Billot L, Norrving B, Anderson CS, Ullberg T. International Care Bundle Evaluation in Cerebral Hemorrhage Research (I-CATCHER): Study protocol for a multicenter, batched, parallel, cluster-randomized trial with a baseline period. Int J Stroke. 2025 Aug;20(7):891-897. doi: 10.1177/17474930251342888. Epub 2025 May 12.
Other Identifiers
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2024-02523-01
Identifier Type: -
Identifier Source: org_study_id
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