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NCT05609110
Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage
Conditions: Intracranial Hemorrhages
Sex: All
Ages: 18 Years – 80 Years
Phase: NA
Enrollment: 2000
Sponsor: Yi Yang
Location: China
Summary
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in treating acute intracerebral hemorrhage.
Eligibility Criteria
Inclusion Criteria:Age 18-80 years.Supratentorial intracerebral hemorrhage confirmed by brain CT scan.Pre-ICH mRS ≤ 1.NIHSS score ≥ 4 and GCS ≥ 8 upon presentation.Able to commence RIC treatment within 24 hours of stroke onset.Systolic blood pressure ≤ 180 mmHg.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.Hematoma with a mid-line shift, cerebral hernia or isolate intraventricular hemorrhage.Already booked for surgical treatment.Life expectancy of less than 90 days due to comorbid conditions.Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban or coagulopathy (defined as INR, APTT, and PT beyond the upper limit of normal range).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, or ALT/AST >3 times upper limit of normal, or serum creatinine >265umol/l.Known pregnancy 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.
Source: ClinicalTrials.gov (NCT05609110). StuddyBuddy aggregates publicly available trial information.