I-CATCHER International Care Bundle Evaluation in Cerebral Hemorrhage Research – a batched parallel cluster-randomized trial with a baseline period

Background/aimThe prognosis after spontaneous intracerebral hemorrhage (ICH) is dismal, with a mortality rate twice as high as that for ischemic stroke.

Treatment is oftentimes affected by pessimism, resulting in underuse of available treatments and overuse of early care limitations.

The aim of the trial is to evaluate if a hyperacute Care Bundle for ICH improves survival and function compared to current standard of care.MethodsThis batched, parallel, cluster-randomized trial with a baseline period has the following aim according to the PICO model:P: Patients ≥18-years, with spontaneous ICH ≤24 hours of onsetI: A hyperacute Care Bundle including early intensive blood pressure lowering, anticoagulant drug reversal, blood glucose and temperature management, referral pathways to neurosurgery or intensive care, and active care for 48 hoursC: Usual careO: Between-group difference in mean utility-weighted modified Rankin Scale score at 180 daysExclusion critera are limited to very severe cases and select pregnant patients.

The trial is powered to detect a 20% difference between groups, with 120 sites/3500 patients.

The trial is Swedish but due to limited number of yearly ICH cases, international sites are to be recruited, including Italy, Canada and Australia. The trial timeline is Oct 1st, 2024–Dec 31st, 2028 (including analyses and presentation at major conferences). SignificanceIf positive, the trial is anticipated to have a profound impact on ICH care within few years.