International Care Bundle Evaluation in Cerebral Hemorrhage Research

PHASE4RecruitingINTERVENTIONAL
Enrollment

3,500

Participants

Timeline

Start Date

January 7, 2025

Primary Completion Date

March 1, 2027

Study Completion Date

September 30, 2027

Conditions
Intracerebral HemorrhageIntracerebral HaemorrhageIntraventricular HemorrhageStrokeCerebrovascular Disease
Interventions
OTHER

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

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

Treatment of pyrexia

To achieve a body temperature target \<37.5 °C within the first 24h following ICH diagnosis on NCCT

OTHER

Hyperglycemia treatment

To maintain a blood glucose level 7-10 mmol/L within the first 24h following ICH diagnosis on NCCT

OTHER

Do-not-resuscitate (DNR) or withdrawal of care

Refrain from the use of DNR or withdrawal of care orders for 48 hours

OTHER

Referral to Intensive Care

Immediate (\<30 min) referral to intensive care if airway, breathing and/or circulation are compromized

OTHER

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"

DIAGNOSTIC_TEST

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

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.

Trial Locations (14)

20502

RECRUITING

Region Skåne, Skåne University Hospital in Malmö, Department of Neurology, Malmo

NSW 2000

NOT_YET_RECRUITING

The George Institute for Global Health, Sydney

K1Y 4E9

NOT_YET_RECRUITING

Ottawa Hospital Research Institute, Ottawa

Unknown

RECRUITING

Hässleholms Sjukhus, Hässleholm

RECRUITING

Helsingborgs Lasarett, Helsingborg

RECRUITING

Blekingesjukhuset, Karlskrona

RECRUITING

Centralsjukhuset Kristianstad, Kristianstad

RECRUITING

Skåne University Hospital Lund Neurosurgery dept, Lund

RECRUITING

Skåne University Hospital Lund, Lund

RECRUITING

Östersunds Lasarett, Östersund

RECRUITING

Länssjukhuset Sundsvall, Sundsvall

RECRUITING

Norrlands Universitetssjukhus, Umeå

RECRUITING

Centrallasarettet Växjö, Vaxjo

RECRUITING

Ystads lasarett, Ystad

Sponsors
All Listed Sponsors
collaborator

The George Institute for Global Health, Australia

OTHER

collaborator

Ottawa Hospital Research Institute

OTHER

lead

Region Skane

OTHER