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Care Bundle Evaluation for Intracerebral Hemorrhage

This study is evaluating a package of treatments for spontaneous intracerebral hemorrhage (ICH), a serious type of stroke where bleeding occurs inside the brain. This treatment package includes quickly reversing the effects of blood thinners like warfarin (using PCC or FFP), lowering high blood pressure to a target of 130-140 mmHg within 30 minutes, treating fever to keep body temperature below 37.5 °C, and managing high blood sugar to maintain levels between 7-10 mmol/L. It also involves avoiding "do-not-resuscitate" orders for the first 48 hours. The study aims to see if these combined treatments improve how well people recover after ICH. You may be able to join if you are an adult (18 or older) with a confirmed ICH diagnosis within 24 hours of symptoms starting.

Study design
This is an interventional study planning to enroll 3500 participants. The specific phase of the study is not mentioned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your functional outcome will be evaluated about 6 months after your diagnosis (180±30 days).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06429332

International Care Bundle Evaluation in Cerebral Hemorrhage Research

Recruiting
PHASE4Ages 18+InterventionalTreatment
Region Skane
~3,500 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Reversal of Oral anticoagulation within 30 minutesEarly intensive blood pressure loweringTreatment of pyrexiaHyperglycemia treatmentDo-not-resuscitate (DNR) or withdrawal of careReferral to Intensive Care

At a glance

Recruiting sites
53 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score
Measured over 180±30 days

Conditions

Intracerebral Hemorrhage
Intracerebral Haemorrhage
Intraventricular Hemorrhage
Stroke
Cerebrovascular Disease

Explore related trials

Cerebral HemorrhageIntraventricular Brain HemorrhageStroke

Where it's being run

54 sites across 8 states
Sweden38
Italy5
Australia3
Ontario3
Malaysia2
Oklahoma1
Hong Kong1
Iceland1

Who to contact

Teresa Ullberg, MD, PhD
[email protected]
0046175057
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score180±30 days

    The modified Rankin Scale (mRS) is an efficient, reliable, and simple functional outcome measure widely used as a primary endpoint in clinical trials for acute stroke. However, being an ordered categorical scale, it may not reflect potentially unequal differences in perceived quality of life associated with certain 1-point shifts vs others. Utility-weighted mRS is a score that weighs the mRS against a health utility scale, which defined as the desirability of a specific health outcome, facilitates comparisons of health-related quality of life across an array of clinical settings. Utility weights, as referred to hereafter, reflect the spectrum between perfect health (a score of 1) and outcomes worse than death (where death is a score of 0 and negative values indicate an outcome worse than death). The primary outcome is UW-mRS at 3 months and will be analyzed by means of a linear regression, with mRS as a dependent variable with 7 levels (0 \[no residual symptom\] to 6 \[death\]).