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International Care Bundle Evaluation in Cerebral Hemorrhage Research

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• Reversal of Oral anticoagulation within 30 minutes (other)
• Early intensive blood pressure lowering (other)
• Treatment of pyrexia (other)
• Hyperglycemia treatment (other)
• Do-not-resuscitate (DNR) or withdrawal of care (other)
• Referral to Intensive Care (other)

Sponsor: Region Skane · Participants: 3,500 · Started: Jan 7, 2025

Contact the study team

• Teresa Ullberg, MD, PhD · Phone: 0046175057

Official record on ClinicalTrials.gov — NCT06429332

Locations in the U.S.

Conditions

• Cerebral Hemorrhage
• Stroke

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.