3,500
Participants
Start Date
January 7, 2025
Primary Completion Date
March 1, 2027
Study Completion Date
September 30, 2027
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.
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.
Treatment of pyrexia
To achieve a body temperature target \<37.5 °C within the first 24h following ICH diagnosis on NCCT
Hyperglycemia treatment
To maintain a blood glucose level 7-10 mmol/L within the first 24h following ICH diagnosis on NCCT
Do-not-resuscitate (DNR) or withdrawal of care
Refrain from the use of DNR or withdrawal of care orders for 48 hours
Referral to Intensive Care
Immediate (\<30 min) referral to intensive care if airway, breathing and/or circulation are compromized
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"
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
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.
RECRUITING
Region Skåne, Skåne University Hospital in Malmö, Department of Neurology, Malmo
NOT_YET_RECRUITING
The George Institute for Global Health, Sydney
NOT_YET_RECRUITING
Ottawa Hospital Research Institute, Ottawa
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
Collaborators (1)
The George Institute for Global Health, Australia
OTHER
Ottawa Hospital Research Institute
OTHER
Region Skane
OTHER