About
I-CATCHER is an international, multicentre, batched, parallel, cluster-randomized clinical trial with a baseline period comparing a Care Bundle with current standard care in patients with spontaneous ICH. In each batch, hospitals are randomized into two groups according to the timing of the intervention (Care Bundle) over 3 phases (usual care, randomized evaluation, post-implementation including a blinded 6-month follow-up) (Figure below). Data collection at baseline (phase 0) and parallel (phase 1) will be used for primary outcome measurement. The study also aims to implement the Care Bundle in routine healthcare in all participating sites after the study period ends (phase 2).
Study Design
The study design will capture consecutive patients with ICH and allow continued intervention 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.
FAQs
What is the primary outcome of the study?
The primary outcome is the Utility-weighted modified Rankin Scale (UW-mRS) score at 6 months (180+30 days).
What are the secondary outcomes of the study?
The secondary clinical efficacy outcomes will be assessed at 6 months: (1) ordinal shift analysis of mRS at 180 days; (2) death (mRS 6); (3) disability (mRS 3–5); (4) poor outcome (mRS 3–6); (5) health-related quality of life (HRQoL); (6) duration of hospitalization.
What are the patient eligibility criteria?
Inclusion criteria: (1) Adults (age ≥18 years), (2) NCCT imaging-verified diagnosis of spontaneous ICH, (3) ≤24 hours from symptom onset or last seen well
Exclusion criteria: (1) Previous care limitation (2) End-stage comorbidity with short life-expectancy (<6 months; e.g. terminal cancer) (3) ICH caused by brain tumour or cerebral venous thrombosis (4) Clinical signs of brain herniation at first presentation (5) Pregnant women beyond 22 gestational weeks may only be included after thorough risk-benefit discussion with an obstetrician
What are the components of the Care Bundle?
Reversal treatment of ongoing OAC ≤30 minutes of hospital admission
Intensive BP lowering: Systolic BP <200 mmHg at admission: systolic target of 130–140 mmHg should be achieved ≤30 minutes of commencing treatment and maintained for the first 7 days. Systolic BP ≥200 and <220 at admission: systolic target of 160 mmHg should be achieved ≤30 minutes, and 130–140 mmHg should be achieved ≤60 minutes. Systolic BP ≥220 at admission: systolic target of 160 mmHg should be achieved ≤60 minutes.
Pyrexia treatment to achieve a body temperature target <37.5 °C
Hyperglycaemia treatment to maintain a blood glucose level 7-10 mmol/L
No use of DNR or withdrawal of care for 48 hours
Immediate (<30 min) referral for intensive care if airway, breathing, and/or circulation are compromised
Immediate (<30 min) referral to neurosurgery if any of the following: Large and/or rapidly evolving supratentorial ICH (>20 ml volume), any IVH extension, posterior fossa bleed, irrespective of volume, suspicion of a vascular malformation, independent of volume or location, altered consciousness or neurological deterioration since symptom onset
Repeat 6–12-hour brain imaging if there is clinical deterioration or if the patient received OAC reversal treatment
How is Standard Care defined?
For patients in the standard care group, decisions regarding the location of care delivery, investigations, monitoring, and all treatments are made by the treating clinical team.
Any other thoughts?
See the protocol for more details regarding I-CATCHER.
