Abstract
Background and rationale: Although many therapies have been investigated for intracerebral hemorrhage (ICH), none have succeeded in improving the functional outcomes. Remote ischemic conditioning (RIC) has been proven to promote hematoma resolution and improve neurological outcomes in an ICH model; whether it is safe and feasible in patients with ICH remains unknown. This trial aims to assess the safety, feasibility, and preliminary efficacy of RIC in patients with ICH and to plan for a phase-2 study.Methods: A proof-of-concept, assessor-blinded, pilot open-label randomized controlled trial will be carried out with patients with ICH within 24–48 h of ictus. All participants will be randomly allocated to the intervention group and the control group with a 1:1 ratio (n = 20) and will be treated with standard managements according to the guidelines. Participants allocated to the intervention group will receive RIC once daily for 7 consecutive days. Cranial computed tomography examinations will be performed at baseline, and on days 3, 7, and 14. Neurological outcomes will be assessed at baseline, and on days 1 to 14, 30, and 90. The primary outcome to be tested is safety. Secondary tested outcomes include changes of hematoma and perihematomal edema volume, incidence of hematoma expansion, functional outcomes, and frequency of adverse events.Discussions: This study will be the first proof-of-concept randomized controlled trial to ascertain the safety, feasibility, and preliminary efficacy of RIC in patients with ICH, results of which will provide parameters for future studies and provide insights into the treatment of ICH.Trial Registration: Clinicaltrials.gov, identifier: NCT03930940.
Highlights
AND RATIONALEIntracerebral hemorrhage (ICH) is a severe neurological disease and public health issue that accounts for 10–15% of strokes in European and American countries and 20–30% of strokes in Asian countries [1, 2]
The Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation III trial that evaluated the efficacy of minimally invasive evacuation followed by thrombolysis in intracerebral hemorrhage (ICH) patients has completed, but it failed to improve functional outcomes despite a significantly decreased hematoma volume [22]
The Intracerebral Haemorrhage Deferoxamine trial found that deferoxamine was safe in patients with ICH and merited further investigation in a phase 3 trial [23]
Summary
AND RATIONALEIntracerebral hemorrhage (ICH) is a severe neurological disease and public health issue that accounts for 10–15% of strokes in European and American countries and 20–30% of strokes in Asian countries [1, 2]. In critically ill patients with aneurysmal subarachnoid hemorrhage, RIC applied in the legs has been demonstrated to be feasible, safe, and well-tolerated, with the potential to prevent delayed cerebral artery spasm and to reduce the incidence of both stroke and death [12,13,14]. Remote ischemic conditioning (RIC) has been proven to promote hematoma resolution and improve neurological outcomes in an ICH model; whether it is safe and feasible in patients with ICH remains unknown. This trial aims to assess the safety, feasibility, and preliminary efficacy of RIC in patients with ICH and to plan for a phase-2 study
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