Remote Ischemic Conditioning in Aneurysmal SAH

NCT06032533 | Recruiting

• 3 other identifiers: 1-16-02-429-227873942304824
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subarachnoid Hemorrhage, Aneurysmal; Delayed Cerebral Ischemia

Keywords

Remote Ischemic Conditioning; Subarachnoid Hemorrhage; Aneurysm; Delayed Cerebral Ischemia

Outcome Measures

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

  Assessed 6 months after initial aneurysm rupture.

Secondary Outcomes (6)

• Difference in Infarct growth

  MRI performed 4-6 weeks after initial hemorrhage.

• Clinical outcome after 14 days measured by modified Rankin scale score (0-6, Higher score indicates worse outcome)

  14 days after initial hemorrhage.

• Occurrence of delayed cerebral ischemia

  Within first 14 days after initial hemorrhage.

• Mortality after 3 months

  Assessed at 3 months post initial hemorrhage

• Mortality after 12 months

  Assessed at 12 months post initial hemorrhage

Study Arms (2)

Remote Ischemic Conditioning

EXPERIMENTAL

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.

Device: Remote Ischemic Conditioning with Automatic Tourniquet Device

Sham-RIC

SHAM COMPARATOR

After randomization a large leg blood pressure cuff will be placed on the lower limb. This cuff will be inflated to 50 mm Hg only. The device will the be operated by trained staff. 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.

Device: Sham Remote Ischemic Conditioning with Automatic Tourniquet Device

Interventions

Remote Ischemic Conditioning with Automatic Tourniquet Device 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.

Remote Ischemic Conditioning

Sham Remote Ischemic Conditioning with Automatic Tourniquet Device 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.

Also known as: Sham

Sham-RIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Concomitant other acute life-threatening medical or surgical condition

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Department of Neurosurgery, Aarhus University Hospital

Aarhus N, Danmark, DK-8200, Denmark

RECRUITING

Related Publications (2)

• Hess DC, Blauenfeldt RA, Andersen G, Hougaard KD, Hoda MN, Ding Y, Ji X. Remote ischaemic conditioning-a new paradigm of self-protection in the brain. Nat Rev Neurol. 2015 Dec;11(12):698-710. doi: 10.1038/nrneurol.2015.223. Epub 2015 Nov 20.

  PMID: 26585977 BACKGROUND

• Gonzalez NR, Connolly M, Dusick JR, Bhakta H, Vespa P. Phase I clinical trial for the feasibility and safety of remote ischemic conditioning for aneurysmal subarachnoid hemorrhage. Neurosurgery. 2014 Nov;75(5):590-8; discussion 598. doi: 10.1227/NEU.0000000000000514.

  PMID: 25072112 BACKGROUND

Related Links

• Background on Aneurysmal Subarachnoid Hemorrhage and Delayed Cerebral Ischemia

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grethe Andersen, Prof., MD

  Department of Neurology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Arzu Bilgin-Freiert, MD, PhD

  Department of Neurosurgery

  STUDY DIRECTOR

Central Study Contacts

Kim M Ørskov, MD

CONTACT

+4542791933; kimoer@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors are recruited from another department, and have not been involved with subjects prior to the telephone interview. Participants and outcome assessors are blinded to subject intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Consultant Neurologist, MD

Model Details: Participants are randomized to either daily treatment with remote ischemic conditioning or daily sham-treatment.

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: September 9, 2023
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 moths and ending 5 years following publication of results
• Access Criteria: Proposals should be directed to kimoer@rm.dk. To gain access data requestors will need to sign a data processing agreement.

Locations

DK (1)