International Care Bundle Evaluation in Cerebral Hemorrhage Research (I-CATCHER)
Background
Spontaneous intracerebral haemorrhage (ICH) accounts for approximately 10-15% of all strokes but stands for 50% of stroke-related morbidity and mortality. Approximately half of all patients with ICH have a decreased level of consciousness at hospital admission. For many years, randomized clinical trial (RCTs) have failed to establish a specific beneficial treatment after ICH. A study conducted in low- and middle-income countries has demonstrated a beneficial effect of a treatment package consisting of early intensive blood pressure lowering, as well as the treatment of pyrexia and elevated blood glucose levels. The I-CATCHER team is now planning to extend the study in Sweden and Australia, as well as to other high-income countries.
Aim
This study aims to investigate whether a structured treatment package (Care Bundle) improves 6-month prognosis in patients with spontaneous ICH compared to standard care.
Research Methodology
I-CATCHER is an international, multicentre, batched, parallel, cluster randomized controlled trial plan to recruit 3500 patients with ICH from 110 hospitals worldwide, including Australia, Sweden, Canada, Italy and additional countries. Hospitals will be activated by batches and randomized into two groups in each batch over 3 phases (usual care, randomized evaluation, post-implementation blinded 6-month follow-up) according to the timing of the intervention (Care Bundle). Each batch period is 18 months (6 months per phase); the whole study will be rolled out in 3 years.
This study has a clear focus on implementation, aiming to bring changes to clinical practice by integrating the care bundle as part of well-organised multidisciplinary care in stroke settings. The study design will capture consecutive patients with ICH and allow continued intervention in perpetuity as more hospitals join. All hospitals will be exposed to the Care Bundle which allows assessment of sustainability and integration of the intervention into routine practice.
Current Status
The study is in the set-up phase. We plan to recruit the first patient in October 2024 and complete it by the end of 2027.
