Remote Ischemic Conditioning with Automatic Tourniquet DeviceSham Remote Ischemic Conditioning with Automatic Tourniquet Device
Remote Ischemic Conditioning with Automatic Tourniquet Device: 5 Cycles of Remote Ischemic Conditioning performed on the leg. One cycle consists of 5 minutes of arterial occlusion followed by 5 minutes of reperfusion. The above is repeated daily for 14 days or until patient is discharged.
Patients are randomized to either active Remote Ischemic Conditioning or Sham-treatment.
Sham Remote Ischemic Conditioning with Automatic Tourniquet Device: 5 Cycles of sham-treatment performed on the leg. One cycle consists of 5 minutes of sham-treatment followed by 5 minutes of pause. The above is repeated daily for 14 days or until patient is discharged.
Patients are randomized to either active Remote Ischemic Conditioning or Sham-treatment.
Study summary
The goal of this clinical trial is to examine the effect of limb occlusion therapy (remote ischemic conditioning, RIC) in subjects with aneurysmal subarachnoid hemorrhage.
The main question it aims to answer is whether RIC can improve long-term recovery in participants with aneurysmal subarachnoid hemorrhage.
Researchers will compare levels of functional independence in participants in the RIC-group to participants in the sham-group.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Clinical outcome after 6 months measured by modified Rankin scale score (0-6, Higher score indicates worse outcome) — Assessed 6 months after initial aneurysm rupture. Assessed by telephone interview. Patient assessor is blinded to intervention
Trial sites (1)
Facility
City
Region
Status
Department of Neurosurgery, Aarhus University Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
