Remote Ischemic Conditioning in Aneurysmal SAH

Launched by AARHUS UNIVERSITY HOSPITAL · Sep 5, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called remote ischemic conditioning (RIC) to see if it helps patients recover better after experiencing a subarachnoid hemorrhage (SAH), which is bleeding in the space around the brain caused by a burst aneurysm. The main goal is to find out if RIC can improve long-term recovery and independence in daily activities compared to a sham (placebo) treatment. Participants will be monitored to see how well they can perform daily tasks after the treatment.

To be eligible for this trial, participants must have had a confirmed aneurysmal subarachnoid hemorrhage within the last three days and must have been able to live independently before their symptoms began. They also need to have had their aneurysm treated with clipping or coiling. Participants should be aware that certain conditions, like severe blood vessel issues or other serious health problems, would prevent them from joining the trial. Throughout the study, participants will receive care and support while being closely observed to assess the effects of the treatment.

Gender

ALL

Eligibility 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