Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage

Yi Yang

Status: Enrolling

Conditions: Intracranial Hemorrhages

Treatments: Device: Sham remote ischemic conditioning; Device: Remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05609110

SERIC-ICH

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in treating acute intracerebral hemorrhage.

Full description

Spontaneous intracerebral hemorrhage is a major cause of disability and mortality among different types of stroke, and few effective treatment options are available. Therefore, it is essential to develop new approaches to improve the prognosis of these patients. Recently, remote ischemic conditioning (RIC), a method that involves inducing multiple brief episodes of ischemia and reperfusion in the limbs, has been indicated to exert neuroprotective effects in experimental stroke. The underlying neuroprotective mechanism triggered by RIC induces gene expression, alters pathways, promotes neurogenesis and blood vessel development, reduces oxidative stress and neuronal apoptosis, and inhibits proinflammatory signals. Previously, several clinical trials have shown that single or repeated RIC treatments for cerebrovascular diseases are feasible and safe. Therefore, we hypothesize that RIC could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled trial to evaluate the efficacy and safety of RIC in treating intracerebral hemorrhage.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years.
2. Supratentorial intracerebral hemorrhage confirmed by brain CT scan.
3. No disability in the community before ICH (premorbid mRS≤ 1).
4. NIHSS score ≥ 6 and GCS ≥ 8 upon presentation.
5. Able to commence RIC treatment within 24 hours of stroke onset.
6. Systolic blood pressure ≤ 180 mmHg before randomization.
7. Signed and dated informed consent is obtained.

Exclusion criteria

1. Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, thrombolytic drug.
2. Hematoma with a mid-line shift, cerebral herniation or isolate intraventricular hemorrhage.
3. Already booked for surgical treatment.
4. Life expectancy of less than 180 days due to comorbid conditions.
5. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban or coagulopathy (defined as INR, APTT, and PT beyond the upper limit of normal range).
6. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC.
7. Severe hepatic and renal dysfunction, or ALT/AST >3 times upper limit of normal, or serum creatinine >265umol/l.
8. Known pregnancy or breastfeeding.
9. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
10. A high likelihood that the patient will not adhere to the study treatment and follow up regimen.
11. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,000 participants in 2 patient groups, including a placebo group

RIC group

Active Comparator group

Description:

Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.

Treatment:

Device: Remote ischemic conditioning

Sham RIC group

Placebo Comparator group

Description:

Sham remote ischemic conditioning (Sham RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.

Treatment:

Device: Sham remote ischemic conditioning