Status:
NOT_YET_RECRUITING
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage
Lead Sponsor:
Yi Yang
Conditions:
Intracranial Hemorrhages
Eligibility:
All Genders
18+ years
Phase:
NA
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 effec...
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 approache...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2027
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT03484936
Start Date
March 15 2026
End Date
June 15 2027
Last Update
October 2 2024
Active Locations (1)
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1
First Hospital of Jilin University
Changchun, Jilin, China, 130000