Using limb occlusion therapy to improve recovery in patients with aneurysmal subarachnoid hemorrhage
The Effect of Remote Ischemic Conditioning on Delayed Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage: A Prospective, Randomized, Patient-assessor Blinded, Sham-controlled Pilot Study Investigating Effect on Clinical Outcome.
This study is testing if a special therapy that temporarily restricts blood flow to the arms or legs can help people recover better after having a brain bleed caused by an aneurysm.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 1 site (Aarhus N, Danmark) |
| Trial ID | NCT06032533 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of remote ischemic conditioning (RIC) on patients who have experienced an aneurysmal subarachnoid hemorrhage (aSAH). Participants will be divided into two groups: one receiving RIC through limb occlusion therapy and the other receiving a sham treatment. The primary aim is to assess whether RIC can enhance long-term functional independence compared to the sham group. The study addresses the critical need for effective interventions to prevent delayed cerebral ischemia, a common and serious complication following aSAH.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with aneurysmal subarachnoid hemorrhage within three days of symptom onset and who were independent in daily living prior to the event.
Not a fit: Patients with subarachnoid hemorrhage from non-aneurysmal causes or those with symptomatic vasospasm at enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients suffering from aneurysmal subarachnoid hemorrhage.
How similar studies have performed: While the concept of remote ischemic conditioning is gaining traction, this specific application in aneurysmal subarachnoid hemorrhage is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aneurysmal subarachnoid hemorrhage confirmed by computed tomography (CT) with aneurysm origin confirmed by computed tomography angiography (CTA) or digital subtraction angiography (DSA) * Aneurysmal subarachnoid hemorrhage symptom-onset ≤ 3 days * Aneurysm protected by clipping or coiling * Independent in daily living before symptom onset (mRS ≤ 2) Exclusion Criteria: * Subarachnoid hemorrhage caused by a lesion other than cerebral aneurysm * Symptomatic vasospasm at the time of enrollment * Previous cerebral lesion e.g. symptomatic cerebral infarction (\>2cm), multiple sclerosis, symptomatic intracerebral hemorrhage, tumour, prior neurosurgery (excluding prior clipping or coiling of cold aneurysms without complications). * History of severe peripheral vascular disease or signs of severe peripheral vascular disease on physical examination * History of deep vein thrombosis or signs of deep vein thrombosis on physical examination * Kidney involvement or prior kidney disease with an estimated glomerular filtration rate (eGFR) below safe levels for contrast infusion in relation to CT-perfusion. * Pregnancy (Women of child-bearing age will have serum-Humane Choriogonadotropine taken prior to final inclusion. If pregnancy cannot be ruled out,the patient can't be included. Women with a safe birth control method will be encouraged to use this method during the entire period of active treatment.) * Concomitant other acute life-threatening medical or surgical condition
Where this trial is running
Aarhus N, Danmark
- Department of Neurosurgery, Aarhus University Hospital — Aarhus N, Danmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Grethe Andersen, Prof., MD — Department of Neurology, Aarhus University Hospital
- Study coordinator: Kim M Ørskov, MD
- Email: kimoer@rm.dk
- Phone: +4542791933
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.