Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote ischemic conditioning, Sham remote ischemic conditioning.
- Who it may be relevant to
- Registry conditions: Intracranial Hemorrhages. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Remote ischemic conditioning
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 mm Hg. RIC will be conducted twice daily for 7 days. - Procedure Sham remote ischemic conditioning
Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.
Primary outcome measures
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 [Time frame: 3 months]
Secondary outcome measures (1)
- Frequency of adverse events [Time frame: 3 months]
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
- Coagulopathy defined as INR,APTT,and PT beyond the upper limit of normal range
- Known pregnancy, or positive pregnancy test, or breastfeeding
- Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial
- A high likelihood that the patient will not adhere to the study treatment and follow up regimen
- Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- First Hospital of Jilin University — Changchun
Identifiers
NCT: NCT03484936 · SERIC-sICH