Clinical trial Recruiting at 53 sites Phase 4 Interventional Ages 18 and up

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.

More Stroke trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment3500 (estimated)
SponsorRegion Skane
Academic / other
Locations54 sites (Oklahoma City, Oklahoma and 53 other locations)
StatusRecruiting
StartedJanuary 7, 2025
Main results expectedMarch 1, 2027
Study endsJuly 2027
Registry record updatedMay 22, 2026
Trial IDNCT06429332 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • AI-assisted transcranial Doppler ultrasound to detect early brain bleeding

    This will try to see if a quick transcranial Doppler ultrasound combined with artificial intelligence can detect intracerebral bleeding in adults with suspected acute stroke within 48 hours of symptom onset.

    Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Catalonia · NCT07319013

  • AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

    This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

    Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

  • NMR-based Risk Test and Digital Health Support for midlife adults in Eloisa

    This study tests whether an NMR metabolomics risk test can guide tailored digital health programs for midlife adults at risk of diabetes, heart disease, stroke, kidney disease, or fatty liver.

    Recruiting University of Eastern Finland · Savonlinna · NCT07820800

  • Savvy medication-support program for people after stroke

    This project will test whether Savvy — short phone-based psychological exercises, a weekly pill organizer, and text reminders — helps stroke survivors take their blood-pressure medicines and improve blood pressure compared with usual care.

    Recruiting Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT07414732

  • When and how people recover after an intracerebral hemorrhage

    This registry will collect detailed, long-term data on adults who have surgery for intracerebral hemorrhage to see if the timing and type of surgical treatment affect recovery and quality of life.

    Recruiting Xuanwu Hospital, Beijing · Beijing · NCT07166146

  • Psilocybin to reopen brain plasticity after chronic stroke

    This trial will test whether a supervised dose of psilocybin is safe and can help reopen brain plasticity in adults who had an ischemic or hemorrhagic stroke at least 12 months ago.

    Recruiting Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT07053917

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.