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)
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 — 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.
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.
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