An interventional study of Remote Ischemic Conditioning with Automatic Tourniquet Device and Sham Remote Ischemic Conditioning with Automatic Tourniquet Device in Subarachnoid Hemorrhage, Aneurysmal and Delayed Cerebral Ischemia, sponsored by Aarhus University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment
Among 22 studies in Subarachnoid Hemorrhage with a site in Denmark — 2 open to participants now, 2 under way, none of them phase 3. Subarachnoid Hemorrhage · Denmark.
Among the 22 studies in Subarachnoid Hemorrhage with a site in Denmark, this one is the 6th largest by planned enrollment of the 13 interventional ones, is one of 3 that started in 2023, is one of 7 with no phase, and was the 22nd registered.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
This study's planned enrollment of 100 is above the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →2 of the 22 studies in Subarachnoid Hemorrhage with a site in Denmark are open now, in 1 country. Each count lists the studies.
Of the 89 Subarachnoid Hemorrhage studies recruiting now, 56 (63%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2023.
Median enrollment 90 across the 13 interventional studies, 70 across the 9 observational. Of the 16 that completed or were terminated, 1 (6%) have results posted.
3 of 22 have an industry lead sponsor. The 7 most frequent:
Aarhus University Hospital is the lead sponsor of 298 studies on the registry; 80 are open to participants now.
Aarhus University Hospital has 1 study filed under Subarachnoid Hemorrhage — fewer than ten, so there is no comparison to draw.
1 of the studies in Subarachnoid Hemorrhage with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06032533Aarhus University HospitalRemote Ischemic Conditioning in Aneurysmal SAH | 2027-11-30 |
Among the 22 studies in Subarachnoid Hemorrhage with a site in Denmark, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Aneurysmal subarachnoid hemorrhage (aSAH) is one of the most devastating types of stroke. Half of the patients die during the acute ictus, and those who survive have a poor prognosis as 20-30% are disabled or eventually die from the disease. In the acute phase after aSAH, the most devastating complication is rebleeding, whereas in the late phase, delayed cerebral ischemia (DCI) is another feared complication, associated with high morbidity and mortality. Symptoms of DCI occur in 30 % of patients and 15-20 % of patients will develop a disabling stroke due to DCI. DCI typically occurs between days 4 and 14 after the initial bleeding. The cause of DCI is not fully understood. Cerebral vasospasms (CVS) are commonly seen on angiography in the first 4-14 days after initial bleeding, and have been linked to late onset of symptoms of focal ischaemia since the 60s. Modern research suggests that the pathophysiology is multifactorial, but CVS is still thought to be a major contributor. Other contributing factors are thought to be microthrombosis, microvascular spasm, oxidative stress, cortically spreading depolarizations, cell death, breakdown of blood-brain barrier, among others. Treatment with nimodipine is standard-of-care and is the only pharmacological intervention that has been shown to improve outcome in aSAH patients, although it has no impact on large-vessel CVS[.
The need for developing effective methods for prevention or treatment of DCI persists, and an effective prophylactic treatment may have a large impact on the general outcome of aSAH.
Ischemic conditioning is a potent activator of endogenous protection against ischemic injury. RIC can be applied as repeated short-lasting ischemia in a distant tissue that results in protection against subsequent long-lasting ischemic injury in the target organ. This protection can be applied prior to or during a prolonged ischemic event as remote ischemic preconditioning (RIPreC) and perconditioning (RIPerC), respectively.
RIC is commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion. RIC activates several protective mechanisms, through humoral and neural pathways and shows promise in the setting of acute stroke.
Inflammation initiated by cerebral ischemia can contribute to secondary brain injury and is correlated with poor outcome. Following ischemia there is a harmful excess leukocyte infiltration in the brain parenchyma, and in experimental studies on aSAH, pharmacological inhibition of cytokines has been associated with improved outcome. RIC has been demonstrated to reduce inflammation and downregulate inflammatory markers. In addition, RIC has protective effects on cerebral endothelial function and induces vasodilation, increasing cerebral blood flow (CBF).
Angiogenesis, erythropoietin and nitric oxide (NO) are suggested to induce neuroprotection and stimulation of these strategies by conditioning including inhibition of inflammation has the potential to play an important part in treatment of patients after aSAH.
The effect of RIC on blood and cerebrospinal fluid biomarkers has never been explored in the setting of aSAH.
To-date, no serious adverse events have been documented in RIC. The procedure has been applied in numerous cardiovascular ischemic patients and in patients suffering from ischemic stroke and cerebral hemorrhage (ICH/SAH).
A recent smaller randomized trials of RIPreC after aSAH showed promising results with regards to functional outcomes and incidence of cerebral oxygen desaturation, likewise without adverse effects of RIC.
RIC is a non-pharmacologic and non-invasive treatment without noticeable discomfort that has neuroprotective potential worldwide.
Aneurysmal SAH and subsequent DCI represents a unique clinical opportunity to test RIC as DCI typically manifests within the first 14 days after ictus and is often a significant contributor to neurological injury. The treatment is feasible, safe, and rooted in well-explored physiological concepts. There is a clear scientific gap and opportunity to explore RIC in the setting of aSAH and DCI in larger randomized trials.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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
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.
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.
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.
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.
Mortality after 3 months
Assessed via patient records. Assessor is blinded to intervention.
Time frame: Assessed at 3 months post initial hemorrhage
Mortality after 12 months
Assessed via patient records. Assessor is blinded to the intervention.
Time frame: Assessed at 12 months post initial hemorrhage
Presence of angiographic vasospasm on CT angiography baseline vs 8-day scan
Evaluated by a neuro-radiologist with more than 10 years of experience in intracerebral angiography. Assessor is blinded to intervention.
Time frame: 8-9 days post initial hemorrhage.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data that underlie the results reported in this article after de-identification of participants
Supporting information: Study protocol, Statistical analysis plan, 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.
Started Sep 2023 (actual). Primary completion is estimated for Nov 2027, 50 months after the start.
Of 57 non-industry interventional studies with no phase under Subarachnoid Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 62. This study's planned 50 months is above that.
Counting every sponsor, half of 67 studies reached it within 32 months; a quarter within 20 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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