Safety , Feasibility and Preliminary Efficacy of Remote Ischemic Conditioning in Patients With Aneurysmal Subarachnoid Hemorrhage After Aneurysm Clipping

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital

About this trial

This study was designed to evaluate the safety and efficacy of remote ischemic conditioning (RIC) in patients with aneurysmal subarachnoid hemorrhage (aSAH) following surgical clipping.

Aneurysmal subarachnoid hemorrhage is a life-threatening condition that occurs when a cerebral aneurysm ruptures, causing bleeding into the subarachnoid space. Surgical clipping of the aneurysm is a standard procedure used to stop the bleeding and prevent re-rupture, thereby stabilizing the patient's condition.

Remote ischemic conditioning (RIC) is a non-invasive treatment that involves using a blood pressure cuff to induce brief, temporary cycles of ischemia and reperfusion in a limb. Research suggests that this process may confer systemic protective effects, potentially improving recovery from brain injury or surgery. Although RIC has shown potential to improve outcomes in patients with other neurological conditions, its effect on patients with aSAH who undergo surgical clipping remains unclear.

This study will evaluate whether RIC can reduce complications, improve neurological function, and enhance overall recovery in these patients. The findings will help determine whether RIC should be incorporated into the standard treatment regimen for aSAH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Imaging examination confirmed aneurysmal subarachnoid hemorrhage.

Responsible aneurysms received craniotomy clipping within 24 hours.

18≤ age ≤80 years old.

Informed consent of the participant or legally authorized representative

Disqualifiers

Patients with other types of cerebral hemorrhage.

Prior neurological impairment (mRS Score >1) or mental illness may confuse neurological or functional assessment.

Severe comorbidities with a life expectancy of less than 90 days.

Refractory hypertension (systolic blood pressure 180>mmHg or diastolic blood pressure 110>mmHg).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remote Ischemic Conditioning Treatment Instrument

    Device

    Remote ischemic conditioning (RIC) was administered twice daily to the unilateral lower limb using a blood pressure cuff inflated to 200 mmHg for 7 consecutive days post-clipping

  • Guideline-based therapy

    Other intervention

    Guideline-based therapy

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: control groupOther 1 intervention
Group B: RIC GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of mRS (0-2)

Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.

Time frame
90±7 days post-enrollment in the study
2

incidence rate of RIC adverse events

RIC adverse events mainly include: limb pain, skin damage, deep vein thrombosis, transient hypertension, etc.

Time frame
From enrollment to the end of RIC at 1 week

Secondary outcomes

1

mRS Score as ordinal variable

Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.

Time frame
7±1 days post-enrollment in the study
2

mRS Score as ordinal variable

Modified Rankin Scale, mRS; min:0, max:6; A smaller score indicates a better prognosis.

Time frame
30±7 days post-enrollment in the study
3

incidence rate of aSAH complications

The complications of aneurysmal subarachnoid hemorrhage mainly include cerebral vasospasm, delayed cerebral ischemia, hydrocephalus, rebleeding, etc.

Time frame
From enrollment to 90 days post-enrollment

Other outcomes

Sponsors and contacts

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