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International Care Bundle Evaluation in Cerebral Hemorrhage Research
Sponsor: Region Skane
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.
Official title: International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3500
Start Date
2025-01-07
Completion Date
2027-07
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (52)
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