Remote Ischemic Conditioning in Aneurysmal SAH
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAarhus University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Remote Ischemic Conditioning with Automatic Tourniquet Device
Device5 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
Device5 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Remote Ischemic ConditioningExperimental treatment 1 intervention
Group B: Sham-RICSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical outcome after 6 months measured by modified Rankin scale score (0-6, Higher score indicates worse outcome)
Assessed by telephone interview. Patient assessor is blinded to intervention
Time frame
Assessed 6 months after initial aneurysm rupture.Secondary outcomes
1
Difference in Infarct growth
Assessed by MRI, measured by segmentation and calculation of infarct volume.
Time frame
MRI performed 4-6 weeks after initial hemorrhage.2
Clinical outcome after 14 days measured by modified Rankin scale score (0-6, Higher score indicates worse outcome)
Assessed by clinician in charge of patient discharge.
Time frame
14 days after initial hemorrhage.3
Occurrence of delayed cerebral ischemia
Neurological deterioration after aSAH where DCI is deemed most likely cause, supported by angiography/perfusion CT.
Time frame
Within first 14 days after initial hemorrhage.4
Mortality after 3 months
Assessed via patient records. Assessor is blinded to intervention.
Time frame
Assessed at 3 months post initial hemorrhageSponsors and contacts
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Source ClinicalTrials.gov