International Care Bundle Evaluation in Cerebral Hemorrhage Research
I-CATCHER
1 other identifier
interventional
3,500
8 countries
52
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2025
Typical duration for phase_4
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2024
CompletedFirst Posted
Study publicly available on registry
May 24, 2024
CompletedStudy Start
First participant enrolled
January 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
February 9, 2026
May 1, 2025
2.1 years
May 14, 2024
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score
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 Outcomes (4)
Ordinal shift analysis of mRS
180 days±30 days
Assessment of health-related quality of life (HRQoL)
180 days±30 days
Poor outcome defined as mRS 3-6
180 days±30 days
Separate outcomes for death and disability
180 days±30 days
Study Arms (2)
Intervention group
ACTIVE COMPARATORA 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
Usual care
PLACEBO COMPARATORFor 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
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.
To achieve a body temperature target \<37.5 °C within the first 24h following ICH diagnosis on NCCT
Immediate (\<30 min) referral to intensive care if airway, breathing and/or circulation are compromized
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 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
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.
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.
To maintain a blood glucose level 7-10 mmol/L within the first 24h following ICH diagnosis on NCCT
Refrain from the use of DNR or withdrawal of care orders for 48 hours
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The George Institute for Global Health, Australiacollaborator
- Ottawa Hospital Research Institutecollaborator
- Region Skanelead
Study Sites (52)
The University of Oklahoma Health
Oklahoma City, Oklahoma, 73126-0901, United States
Royal Adelaide Hospital
Adelaide, 5000, Australia
Monash Medical Centre
Clayton, 3168, Australia
The George Institute for Global Health
Sydney, NSW 2000, Australia
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9, Canada
Hong Kong University Hospital
Hong Kong, Hong Kong
Landspitali University Hospital
Reykjavik, 105, Iceland
Avezzano Ospedale SS. Filippo e Nicola
Avezzano, 67051, Italy
Citta di Castello Ospedale Città di Castello
Città di Castello, 06012, Italy
Gubbio Ospedale di Gubbio e Gualdo Tadino
Gubbio, Italy, Italy
Azienda Ospedaliera Santa Maria della Misericordia Perugia
Perugia, 06129, Italy
Roma Policlinico Gemelli
Roma, 00136, Italy
National University of Malaysia Hospital
Kuala Lumpur, 56000, Malaysia
Universiti Putra Malaysia Hospital
Serdang, 43400, Malaysia
Höglandssjukhuset i Eksjö
Eksjö, 575 81, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Östra Sjukhuset
Gothenburg, 41685, Sweden
Hässleholms Sjukhus
Hässleholm, Sweden
Helsingborgs Lasarett
Helsingborg, Sweden
Karolinska Universitetssjukhuset Huddinge
Huddinge, Sweden
Länssjukhuset Ryhov
Jönköping, 551 85, Sweden
Länssjukhuset Kalmar
Kalmar, 391 85, Sweden
Blekingesjukhuset Karlskrona
Karlskrona, 371 41, Sweden
Blekingesjukhuset
Karlskrona, Sweden
Centralsjukhuset Karlstad
Karlstad, 651 85, Sweden
Västmanlands sjukhus Köping
Köping, 731 81, Sweden
Centralsjukhuset Kristianstad
Kristianstad, Sweden
Kungälvs sjukhus
Kungälv, 442 83, Sweden
Univeristetssjukhuset Linköping
Linköping, 581 85, Sweden
Ljungby Lasarett
Ljungby, 341 35, 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, 20502, Sweden
Mölndals Sjukhus
Mölndal, 431 80, Sweden
Oskarshamn Sjukhus
Oskarshamn, 572 28, Sweden
Universitetssjukhuset Örebro
Örebro, 701 85, Sweden
Östersunds Lasarett
Östersund, Sweden
Skaraborgs Sjukhus Skövde
Skövde, 541 85, Sweden
Capio St Görans Sjukhus
Stockholm, 112 81, Sweden
Södersjukhuset
Stockholm, 118 83, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Danderyds sjukhus
Stockholm, 182 88, Sweden
Länssjukhuset Sundsvall
Sundsvall, Sweden
Norra Älvsborgs Länssjukhus
Trollhättan, 461 85, Sweden
Norrlands Universitetssjukhus
Umeå, Sweden
Lasarettet i Enköping
Uppsala, 751 85, Sweden
Akademiska Sjukhuset Uppsal
Uppsala, 75185, Sweden
Hallands sjukhus Varberg
Varberg, 43237, Sweden
Centrallasarettet Växjö
Vaxjo, Sweden
Värnamo sjukhus
Värnamo, 331 85, Sweden
Västerås
Västerås, 721 89, Sweden
Ystads lasarett
Ystad, Sweden
Related Publications (9)
GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
PMID: 34487721BACKGROUNDQureshi 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.
PMID: 11346811BACKGROUNDvan 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.
PMID: 20056489BACKGROUNDParry-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.
PMID: 31291031BACKGROUNDHemphill 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.
PMID: 15044768BACKGROUNDBecker 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.
PMID: 11274312BACKGROUNDZahuranec 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.
PMID: 17502545BACKGROUNDSong L, Hu X, Ma L, Chen X, Ouyang M, Billot L, Li Q, Munoz-Venturelli P, Abanto C, Pontes-Neto OM, Antonio A, Wasay M, Silva A, Thang NH, Pandian JD, Wahab KW, You C, Anderson CS; INTERACT3 investigators. INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial. Trials. 2021 Dec 20;22(1):943. doi: 10.1186/s13063-021-05881-7.
PMID: 34930428BACKGROUNDApostolaki-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.
PMID: 40356012DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Treatment allocation is on a site-level and not on an individual level. The allocation is not blinded. Follow-up clinical outcome assessors, who have no prior association with the study and are unaware of the patients' allocation to either the intervention or control arm, will contact the participant by telephone at 6 months. At the initiation of contact, study subjects will be urged not to disclose their treatment allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2024
First Posted
May 24, 2024
Study Start
January 7, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
February 9, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share