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

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 15, 2022

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.

Arms, Groups and Cohorts

  • Active Comparator: RIC+Standard medical treatment
    • 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. Additionally,the patients will be treated with standard medical treatment according to 2014 chinese guideline for the diagnosis and treatment of intracerebral hemorrhage.
  • Placebo Comparator: Sham RIC+Standard medical treatment
    • Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.Additionally,the patients will be treated with standard medical treatment according to 2014 chinese guideline for the diagnosis and treatment of intracerebral hemorrhage.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of patients with Modified Rankin Scale (mRS) Score 0-2
    • Time Frame: 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.

Secondary Measures

  • Frequency of adverse events
    • Time Frame: 3 months
    • The safety endpoints will include all adverse events until day-7 or discharge (whichever is earlier), and severe adverse events through day-90 after the onset of intracerebral hemorrhage.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yi Yang
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Yi Yang, Associated Dean of First Hospital of Jilin University – First Hospital of Jilin University
  • Overall Official(s)
    • Yi Yang, MD, PhD, Study Chair, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
  • Overall Contact(s)
    • Yi Yang, MD, PhD, 0086-13756661217, doctor_yangyi@163.com

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