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. Despite this, intensive care and neurosurgical interventions are uncommon. 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 conduct a similar study in Sweden and Australia, as well as in other high-income countries. The study has a clear focus on implementation, aiming to improve treatment and prognosis for patients with ICH within a few years. The purpose of I-CATCHER is to investigate whether a structured treatment package (Care Bundle) improves 3-month prognosis in patients with spontaneous ICH compared to standard care.
Adults (age ≥18 years)
Non-contrast computerized tomography (NCCT) imaging-verified diagnosis of spontaneous intracerebral haemorrhage
≤24 hours from symptom onset or presumed symptom onset (last seen well)
Previous care limitation
End-stage comorbidity with short life-expectancy (<6 m; e.g. terminal cancer)
ICH caused by brain tumor or cerebral venous thrombosis
Clinical signs of brain herniation at first presentation (unresponsive patient with bilaterally fixed, maximally dilated pupils)
Parallel
Reversal of Oral anticoagulation within 30 minutes
Other interventionIn 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
Other interventionA 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
Other interventionTo achieve a body temperature target \<37.5 °C within the first 24h following ICH diagnosis on NCCT
Hyperglycemia treatment
Other interventionTo 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
Other interventionRefrain from the use of DNR or withdrawal of care orders for 48 hours
Referral to Intensive Care
Other interventionImmediate (\<30 min) referral to intensive care if airway, breathing and/or circulation are compromized
Referral to Neurosurgery
Other interventionImmediate (\<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
Diagnostic testRepeat 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
Other interventionFor 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.
Evaluation of functional outcome based on the Utility Weighted modified Rankin Scale score
The modified Rankin Scale (mRS) is an efficient, reliable, and simple functional outcome measure widely used as a primary endpoint in clinical trials for acute stroke. However, being an ordered categorical scale, it may not reflect potentially unequal differences in perceived quality of life associated with certain 1-point shifts vs others. Utility-weighted mRS is a score that weighs the mRS against a health utility scale, which defined as the desirability of a specific health outcome, facilitates comparisons of health-related quality of life across an array of clinical settings. Utility weights, as referred to hereafter, reflect the spectrum between perfect health (a score of 1) and outcomes worse than death (where death is a score of 0 and negative values indicate an outcome worse than death). The primary outcome is UW-mRS at 3 months and will be analyzed by means of a linear regression, with mRS as a dependent variable with 7 levels (0 \[no residual symptom\] to 6 \[death\]).
Ordinal shift analysis of mRS
The assessment of shifts in the distribution of mRS scores through the evaluation of scores in ordinal groups
Assessment of health-related quality of life (HRQoL)
This will be assessed using the EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D). The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Poor outcome defined as mRS 3-6
Binary secondary outcomes will be analyzed by means of standard GEE or random-effects regression with a logistic link and/or time-to-event type endpoints using the Cox model with a sandwich formula or a frailty model.
Separate outcomes for death and disability
Binary secondary outcomes will be analyzed by means of standard GEE or random-effects regression with a logistic link and/or time-to-event type endpoints using the Cox model with a sandwich formula or a frailty model.
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Region Skane
Lead sponsor
The George Institute for Global Health, Australia
Collaborator
Ottawa Hospital Research Institute
Collaborator