Remote Ischemic Conditioning in Aneurysmal SAH (RESCUE-SAH)
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring Remote Ischemic Conditioning, Subarachnoid Hemorrhage, Aneurysm, Delayed Cerebral Ischemia
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
Sites / Locations
- Department of Neurosurgery, Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Remote Ischemic Conditioning
Sham-RIC
After randomization a large thigh blood pressure cuff will be placed on the lower limb. The cuff will be inflated to a pressure 30 mm Hg greater than the systolic arterial blood pressure measured by the patient's arterial line or upper limb blood pressure cuff. The adequate level of inflation will be confirmed by the absence of pulse in the ipsilateral pedal artery detected by palpation. If the pulse signal is still present, the cuff will be inflated further until it disappears. The cuff will remain inflated for 5 minutes. Then the cuff will be deflated and the limb allowed to re-perfuse for 5 minutes. The procedure will be repeated five times followed by reperfusion. The first session will be performed 24-72 hours after the initial hemorrhage, within the first 24 hours after treatment of aneurysm, and repeated every 24 hours, between 8-10 am, until post hemorrhagic day 14.
After randomization a large leg blood pressure cuff will be placed on the lower limb. This cuff is not attached to the device, but appears to be. The device will the be operated by trained staff. A hidden cuff is attached to the device to ensure that the device produces regular operation noises. The hidden cuff (not attached to patient) is inflated. The cuff will remain inflated for 5 minutes, then the cuff will be deflated for 5 minutes. The procedure will be repeated for five cycles. The first session will be performed 48-72 hours after the initial hemorrhage, at least 24 hours after treatment of aneurysm and repeated every 24 hours, between 8-10 am, until post hemorrhagic day 14.