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Clinical Trials in China / NCT03484936
Starting soon Not applicable

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage

NCT03484936 · tracked via the Priya Life Science China tracker
Sponsor
Yi Yang
Phase
Not applicable
Started
2026-03-15
Last updated
2024-10-02

Condition(s) studied

Intracranial Hemorrhages

Investigational drug(s) / intervention(s)

Remote ischemic conditioningSham remote ischemic conditioning

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.

Sham remote ischemic conditioning: Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years 2. Supratentorial intracerebral hemorrhage confirmed by brain CT scan 3. Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1 4. NIHSS score ≥ 4 and GCS ≥ 6 upon presentation 5. Able to commence RIC treatment within 12 hours of stroke onset 6. Signed and dated informed consent is obtained. Exclusion Criteria: 1. Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes 2. A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria 3. Already booked for surgical treatment 4. Life expectancy of less than 90 days due to comorbid conditions 5. Severe hematologic disease 6. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban. 7. Concurrent use of glibenclamide or nicorandil 8. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC 9. Severe hepatic and renal dysfunction 10. Platelet count \<100×10\^9/L 11. Coagulopathy defined as INR,APTT,and PT beyond the upper limit of normal range 12. Known pregnancy, or positive pregnancy test, or breastfeeding 13. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial 14. A high likelihood that the patient will not adhere to the study treatment and follow up regimen 15. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
First Hospital of Jilin University Changchun Jilin

More Yi Yang trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03484936 on ClinicalTrials.gov ↗ ← All trials in China