Remote ischaemic conditioning-a new paradigm of self-protection in the brain.
David C Hess, Rolf A Blauenfeldt, Grethe Andersen...
https://pubmed.ncbi.nlm.nih.gov/26585977Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06032533
The Effect of Remote Ischemic Conditioning on Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage: A Randomized, Patient-assessor Blinded, Sham-controlled Pilot Study on Clinical Outcome
Led by Aarhus University Hospital · Updated on 2025-10-03
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of remote ischemic conditioning (RIC), a therapy using repeated short cycles of limb blood flow restriction and reperfusion, in patients with aneurysmal subarachnoid hemorrhage (aSAH). This serious type of stroke often leads to complications such as delayed cerebral ischemia (DCI), which occurs in 30% of patients and causes significant disability or death. The study aims to determine if RIC can improve long-term functional independence compared to a sham treatment. Participants are randomly assigned to one of two groups: the RIC group receives five cycles of 5-minute blood flow restriction followed by 5 minutes of reperfusion on the leg daily for up to 14 days, starting within 24 to 72 hours after hemorrhage and aneurysm treatment. The sham group undergoes a similar procedure with cuff inflation only to 50 mm Hg, which does not block blood flow, repeated daily for the same duration. Both treatments are delivered using an automatic tourniquet device. During the study, participants will be assessed for clinical outcomes using the modified Rankin scale at 14 days and 6 months, brain imaging to measure infarct growth, and the occurrence of delayed cerebral ischemia. Researchers will also monitor mortality at 3 and 12 months and angiographic vasospasm. The study includes safety monitoring and will last several months to capture long-term recovery data.
CONDITIONS
Brief Title
Remote Ischemic Conditioning in Aneurysmal SAH
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aneurysmal subarachnoid hemorrhage confirmed by CT with aneurysm origin confirmed by CTA or DSA
- Symptom onset of aneurysmal subarachnoid hemorrhage within 3 days
- Aneurysm treated by clipping or coiling
- Independence in daily living before symptom onset (modified Rankin scale score 0 to 2)
You will not qualify if you...
- Subarachnoid hemorrhage caused by a lesion other than cerebral aneurysm
- Symptomatic vasospasm at the time of enrollment
- Previous cerebral lesions such as symptomatic cerebral infarction larger than 2 cm, multiple sclerosis, symptomatic intracerebral hemorrhage, tumor, or prior neurosurgery (except uncomplicated prior clipping or coiling of cold aneurysms)
- History or signs of severe peripheral vascular disease
- History or signs of deep vein thrombosis
- Kidney disease with low estimated glomerular filtration rate unsafe for contrast infusion
- Pregnancy or inability to rule out pregnancy
- Other acute life-threatening medical or surgical conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Daily for up to 14 days or until discharge
Participants receive Remote Ischemic Conditioning or sham treatment involving cycles of blood pressure cuff inflation and deflation on the leg to activate protective mechanisms against delayed cerebral ischemia.
Daily visits for treatment sessions between 8-10 am
Follow-up
Duration - Up to 12 months
Participants are monitored for clinical outcomes and potential delayed cerebral ischemia after treatment ends.
Assessments at 14 days, 3 months, 6 months, and 12 months after initial hemorrhage
Trial Site Locations
Total: 1 location
1
Department of Neurosurgery, Aarhus University Hospital
Aarhus N, Danmark, Denmark, DK-8200
Actively Recruiting
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Research Team
K
Kim M Ørskov, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Phase I clinical trial for the feasibility and safety of remote ischemic conditioning for aneurysmal subarachnoid hemorrhage.
Nestor R Gonzalez, Mark Connolly, Joshua R Dusick...
https://pubmed.ncbi.nlm.nih.gov/25072112