Phase 4Recruiting

Testing Reversal of with Early intensive blood pressure lowering against a placebo for intracerebral hemorrhage

Official title: 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

Condition: Intracerebral HemorrhageSponsor: Region SkaneTarget enrollment: 3500

Phase 4
2 groups
Sites in Greater Sudbury, Hamilton and 1 more city
Recruiting

Interventions (9)

Other intervention
Reversal of Oral anticoagulation within 30 minutes
In situations of either an elevated INR with the use of warfarin - treatment with either 3- or 4-factor prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP) within 30 minutes of ICH diagnosis on NCCT to reach and maintain an INR target \<1.3; or where there has been recent use (\<48 hours) of a direct oral anticoagulant (DOAC), use of an appropriate reversal agent within 30 minutes, where available, and according to local approvals.
Other intervention
Early intensive blood pressure lowering
A systolic blood pressure (BP) target of 130-140 mmHg within 30 minutes of ICH diagnosis on NCCT is strived for, and to maintain this BP level for the first 7 days (for patients presenting with blood pressure \<200 mmHg). If blood pressure ≥200 and \<220, a target BP of 160 mmHg should be targeted at 30 minutes, and 130-140 mmHg should be achieved in 60 minutes. If BP ≥220, target BP of 160 mmHg and should be achieved in 60 minutes.
Other intervention
Treatment of pyrexia
To achieve a body temperature target \<37.5 °C within the first 24h following ICH diagnosis on NCCT
Other intervention
Hyperglycemia treatment
To maintain a blood glucose level 7-10 mmol/L within the first 24h following ICH diagnosis on NCCT
Other intervention
Do-not-resuscitate (DNR) or withdrawal of care
Refrain from the use of DNR or withdrawal of care orders for 48 hours
Other intervention
Referral to Intensive Care
Immediate (\<30 min) referral to intensive care if airway, breathing and/or circulation are compromized
Other intervention
Referral to Neurosurgery
Immediate (\<30 min) referral to neurosurgery if any of the following criteria are fulfilled: * Large and/or rapidly evolving supratentorial ICH (\>20 ml volume) * Any intraventricular extension * Posterior fossa bleed, irrespective of volume * Suspicion of a vascular malformation, independent of volume or location * Reduction in reaction to sensory stimulation or drowsiness
Other intervention
Repeat brain imaging
Repeat 6-12-hour brain imaging with the physicians choice of modality, preferably computed tomography (CT), if clinical deterioration or the patient received OAC reversal treatment
Other intervention
Standard care
For patients in the usual-care group, decisions about the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team. Data will be collected regarding the management of patients, including insertion of invasive monitoring devices, intravenous fluid resuscitation, BP lowering, vasoactive support, glycemic control, mechanical ventilation, neurosurgery, and other supportive therapy.

Canadian Sites (3)

3 of 3 recruiting

Health Sciences North/Health Sciences North Research Institute
Greater Sudbury, Ontario
Recruiting
Hamilton General Hospital
Hamilton, Ontario
Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario
Recruiting

See who this study is looking for8 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

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.

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 4 — a study of a treatment already approved for use, following it in everyday practice.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases

Who receives what

There are 2 groups in this study.

Group A, the comparison group, receives one or more of: Reversal of Oral anticoagulation within 30 minutes, Early intensive blood pressure lowering, Treatment of pyrexia, Hyperglycemia treatment, Do-not-resuscitate (DNR) or withdrawal of care, Referral to Intensive Care, Referral to Neurosurgery and Repeat brain imaging.

Registry label: A: Intervention group

Group B, the placebo group, receives Standard care.

Registry label: B: Usual care

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].label
armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

One group receives a placebo — a dummy treatment with no active medicine in it.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 3,500 people.

The study is currently expected to finish around July 2027.

The main measurement is taken over: 180±30 days.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score — measured over 180±30 days.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06429332 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Reversal of Oral anticoagulation within 30 minutesOther

In situations of either an elevated INR with the use of warfarin - treatment with either 3- or 4-factor prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP) within 30 minutes of ICH diagnosis on NCCT to reach and maintain an INR target \<1.3; or where there has been recent use (\<48 hours) of a direct oral anticoagulant (DOAC), use of an appropriate reversal agent within 30 minutes, where available, and according to local approvals.