Care bundle to improve recovery after intracerebral haemorrhage
Official title: International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period
Run by Region Skane · NCT06429332 · Data updated 2026-11-12
This trial will try a structured treatment package—rapid reversal of blood thinners when needed, early intensive blood pressure lowering, and treatment of fever and high blood sugar—to see if it improves 3‑month outcomes for adults with spontaneous intracerebral haemorrhage who arrive within 24 hours of symptom onset.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 3500 (estimated) |
| Sponsor | Region Skane Academic / other |
| Locations | 54 sites (Oklahoma City, Oklahoma and 53 other locations) |
| Status | Recruiting |
| Started | January 7, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | July 2027 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT06429332 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with non-contrast CT–confirmed spontaneous intracerebral haemorrhage presenting within 24 hours of symptom onset and without prior care limitations are ideal candidates.
✕Probably not a fit
Patients with ICH caused by brain tumor or cerebral venous thrombosis, those with clinical signs of brain herniation at presentation, or those with very short expected survival are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial implements a standardized Care Bundle for acute intracerebral haemorrhage that includes rapid reversal of oral anticoagulation (when indicated), early intensive blood pressure lowering, treatment of pyrexia, and control of hyperglycemia, alongside guidance on escalation or limitation of care. Participating hospitals will adopt the bundle as part of routine acute management and outcomes before and after implementation will be compared, with the primary endpoint measured at 3 months. The design emphasizes practical implementation across high‑income country centers to see whether benefits observed previously in lower‑ and middle‑income settings can be replicated. Eligibility focuses on adults with CT‑confirmed spontaneous ICH presenting within 24 hours, excluding patients with non-spontaneous causes, clinical brain herniation, or very limited life expectancy.
Why it matters
Potential benefit: If successful, the Care Bundle could lower death and disability at 3 months by standardizing early acute care for ICH.
How similar studies have gone: Previous cluster implementation work, most notably the INTERACT3 program in lower- and middle-income countries, showed beneficial effects of a similar care bundle.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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The University of Oklahoma Health
Oklahoma City, Oklahoma, United States Recruiting -
Royal Adelaide Hospital
Adelaide, Australia Recruiting -
Monash Medical Centre
Clayton, Australia Recruiting -
Health Sciences North/Health Sciences North Research Institute
Greater Sudbury, Ontario, Canada Recruiting -
Hamilton General Hospital
Hamilton, Ontario, Canada Recruiting -
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada Recruiting
Show 44 more locations
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Hong Kong University Hospital
Hong Kong, Hong Kong Recruiting -
Landspitali University Hospital
Reykjavik, Iceland Recruiting -
Avezzano Ospedale SS. Filippo e Nicola
Avezzano, Italy Recruiting -
Citta di Castello Ospedale Città di Castello
Città di Castello, Italy Recruiting -
Gubbio Ospedale di Gubbio e Gualdo Tadino
Gubbio, Italy Recruiting -
Azienda Ospedaliera Santa Maria della Misericordia Perugia
Perugia, Italy Recruiting -
Roma Policlinico Gemelli
Roma, Italy Recruiting -
National University of Malaysia Hospital
Kuala Lumpur, Malaysia Recruiting -
Universiti Putra Malaysia Hospital
Serdang, Malaysia Recruiting -
Höglandssjukhuset i Eksjö
Eksjö, Sweden Recruiting -
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden Recruiting -
Östra Sjukhuset
Gothenburg, Sweden Recruiting -
Hässleholms Sjukhus
Hässleholm, Sweden Recruiting -
Helsingborgs Lasarett
Helsingborg, Sweden Recruiting -
Karolinska Universitetssjukhuset Huddinge
Huddinge, Sweden Recruiting -
Länssjukhuset Ryhov
Jönköping, Sweden Recruiting -
Länssjukhuset Kalmar
Kalmar, Sweden Recruiting -
Blekingesjukhuset Karlskrona
Karlskrona, Sweden Recruiting -
Blekingesjukhuset
Karlskrona, Sweden Recruiting -
Centralsjukhuset Karlstad
Karlstad, Sweden Recruiting -
Västmanlands sjukhus Köping
Köping, Sweden Recruiting -
Centralsjukhuset Kristianstad
Kristianstad, Sweden Recruiting -
Kungälvs sjukhus
Kungälv, Sweden Recruiting -
Univeristetssjukhuset Linköping
Linköping, Sweden Recruiting -
Ljungby Lasarett
Ljungby, Sweden Recruiting -
Skåne University Hospital Lund Neurosurgery dept
Lund, Sweden Recruiting -
Skåne University Hospital Lund
Lund, Sweden Recruiting -
Region Skåne, Skåne University Hospital in Malmö, Department of Neurology
Malmö, Sweden Recruiting -
Mölndals Sjukhus
Mölndal, Sweden Recruiting -
Oskarshamn Sjukhus
Oskarshamn, Sweden Recruiting -
Universitetssjukhuset Örebro
Örebro, Sweden Recruiting -
Östersunds Lasarett
Östersund, Sweden Recruiting -
Skaraborgs Sjukhus Skövde
Skövde, Sweden Recruiting -
Capio St Görans Sjukhus
Stockholm, Sweden Recruiting -
Södersjukhuset
Stockholm, Sweden Recruiting -
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden Recruiting -
Danderyds sjukhus
Stockholm, Sweden Recruiting -
Länssjukhuset Sundsvall
Sundsvall, Sweden Recruiting -
Norra Älvsborgs Länssjukhus
Trollhättan, Sweden Recruiting -
Norrlands Universitetssjukhus
Umeå, Sweden Recruiting -
Lasarettet i Enköping
Uppsala, Sweden Recruiting -
Akademiska Sjukhuset Uppsal
Uppsala, Sweden Recruiting -
Hallands sjukhus Varberg
Varberg, Sweden Recruiting -
Centrallasarettet Växjö
Vaxjo, Sweden Recruiting
+4 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Teresa Ullberg, MD, PhD
- Email: i-catcher@med.lu.se
- Phone: 0046175057
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.