Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Hemorrhages
- Sponsor
- Yi Yang
- Enrollment
- 530
- Locations
- 1
- Primary Endpoint
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.
Detailed Description
Intracerebral hemorrhage is a devastating disease with a high rate of severe disability and death, while no specific treatment has been proven to improve functional outcome. As a result, new approaches need to be developed to treat intracerebral hemorrhage. Animal and human trials showed treatment with remote ischemic conditioning was safe for intracerebral hemorrhage. And repetitive remote ischemic conditioning has been shown to improve sensorimotor and neuropathological outcomes following experimental hemorrhagic stroke. Therefore, we hypothesize that repetitive remote ischemic conditioning could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled double-blind trial to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.
Investigators
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Supratentorial intracerebral hemorrhage confirmed by brain CT scan
- •Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
- •NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
- •Able to commence RIC treatment within 12 hours of stroke onset
- •Signed and dated informed consent is obtained.
Exclusion Criteria
- •Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
- •A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
- •Already booked for surgical treatment
- •Life expectancy of less than 90 days due to comorbid conditions
- •Severe hematologic disease
- •Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban.
- •Concurrent use of glibenclamide or nicorandil
- •Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC
- •Severe hepatic and renal dysfunction
- •Platelet count \<100×10\^9/L
Outcomes
Primary Outcomes
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
Time Frame: 3 months
The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.
Secondary Outcomes
- Frequency of adverse events(3 months)