Key result
Pilot RCT tests remote ischemic conditioning safety and feasibility in aneurysmal subarachnoid hemorrhage.
Why the study?
Current research on remote ischemic conditioning in aneurysmal subarachnoid hemorrhage patients has focused on safety but lacks high-level evidence for effectiveness.
Does remote ischemic conditioning improve 90-day functional outcomes and demonstrate safety when added to standard management in patients with aneurysmal subarachnoid hemorrhage after microsurgical clipping?
RCT (n=40)
Open-label, evaluator-blinded
Computer-generated sequence (1:1 ratio)
Yes
Does remote ischemic conditioning improve 90-day functional outcomes and demonstrate safety when added to standard management in patients with aneurysmal subarachnoid hemorrhage after microsurgical clipping?
This trial protocol outlines an evaluator-blinded pilot RCT to determine whether lower-limb remote ischemic conditioning is safe, feasible, and effective at improving 90-day functional outcomes in patients with aneurysmal subarachnoid hemorrhage following microsurgical clipping.
Planned 40-patient RCT will generate first safety and feasibility data on remote ischemic conditioning in aneurysmal subarachnoid hemorrhage; leaves efficacy open pending larger trials.
Background and rationale: Aneurysmal subarachnoid hemorrhage (aSAH) is a severe cerebrovascular event with a high mortality and disability rate. Compared to interventional surgery, microsurgical clipping is more invasive and has a higher incidence of postoperative complications, including cerebral vasospasm and ischemic cerebral infarction. In recent years, a large number of basic experiments have proved that remote ischemic conditioning (RIC) has multiple pathways of neuroprotective effects, and many large-scale randomized controlled clinical trials have confirmed that remote ischemic conditioning applied to patients with ischemic stroke has the effect of improving prognosis. However, current research has only focused on demonstrating the safety of remote ischemic conditioning for patients with aSAH, and lacks high-level evidence for its effectiveness. Method: = 20), and will receive standard management according to the guidelines. Participants assigned to the intervention group will receive RIC twice a day, once in the morning and once in the afternoon, for 7 consecutive days after the operation. Neurological prognosis will be evaluated at baseline, day 3, day 7, day 30, and day 90. The primary outcome measure is the proportion of patients with a mRS score of 0-2 at 90 ± 7 days after surgery and the incidence rate of RIC adverse events. The secondary measures include the incidence of aSAH complications, the mRS score of patients 30 ± 7 days after surgery, and the mRS score of patients 7 ± 1 day after surgery. Discussion: The study's aim is to explore the safety, feasibility and preliminary efficacy of RIC in aSAH patients after clipping surgery. It serves as a methodological and feasibility foundation for the later multicenter, double-blind REPAIR trial (NCT06711302), which aims to confirm efficacy in a larger population. Clinical trial registration: https://clinicaltrials.gov/study/NCT06819657?term=NCT06819657&rank=1, NCT06819657.
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Xu et al. (2025) conducted an RCT in Aneurysmal subarachnoid hemorrhage (aSAH) (n=40). Remote ischemic conditioning (RIC) vs. Standard management was evaluated on Proportion of patients achieving a good functional outcome (mRS score 0-2) at 90 ± 7 days after surgery, and the incidence rate of RIC-related adverse events. Remote ischemic conditioning will be evaluated for safety, feasibility, and preliminary efficacy in a planned 40-patient randomized controlled trial of patients with aneurysmal subarachnoid hemorrhage.
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