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Care bundle to improve recovery after intracerebral haemorrhage

International Care Bundle Evaluation in Cerebral Hemorrhage Research - a Batched Parallel Cluster-randomized Trial With a Baseline Period

Phase 4 Interventional Region Skane · NCT06429332

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

PhasePhase 4
Study typeInterventional
Enrollment3500 (estimated)
Ages18 Years and up
SexAll
SponsorRegion Skane Academic / other
Locations52 sites (Oklahoma City, Oklahoma and 51 other locations)
Trial IDNCT06429332 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Previous cluster implementation work, most notably the INTERACT3 program in lower- and middle-income countries, showed beneficial effects of a similar care bundle.

Eligibility criteria

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 this trial is running

Oklahoma City, Oklahoma and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Intracerebral HemorrhageIntracerebral HaemorrhageIntraventricular HemorrhageStrokeCerebrovascular Diseaseintracerebral hemorrhageoral anticoagulantblood pressure lowering
Last reviewed 2026-06-13 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.