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Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage (SERIC-sICH)

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ClinicalTrials.gov Identifier: NCT03484936
Recruitment Status : Not yet recruiting
First Posted : April 2, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Yi Yang, First Hospital of Jilin University

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 effectiveness as a treatment for intracerebral hemorrhage.

Condition or disease Intervention/treatment Phase
Intracranial Hemorrhages Procedure: Remote ischemic conditioning Procedure: Sham remote ischemic conditioning Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage
Estimated Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.
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.
Other Name: RIC

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Proportion of hematoma growth [ Time Frame: 24 hours ]
    The proportional growth in hematoma volume during the first 24h after the onset of intracerebral hemorrhage.

  2. Proportion of hematoma absorption [ Time Frame: 14 days ]
    The proportional change in hematoma volume between 24h and 14 days or discharge (whichever is earlier) after the onset of intracerebral hemorrhage.

  3. Changes of hematological indicators [ Time Frame: 24 hours; 7 days ]
    The changes of hematological indicators (inflammatory cytokine,et al.) during the first 24h and 7 days after the onset of intracerebral hemorrhage.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484936


Contacts
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Contact: Yi Yang, MD, PhD 0086-13756661217 doctor_yangyi@163.com
Contact: Zhenni Guo, MD zhen1ni2@163.com

Locations
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China, Jilin
First Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130000
Contact: Yi Yang, MD, PhD       doctor_yangyi@163.com   
Sponsors and Collaborators
Yi Yang
Investigators
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Study Chair: Yi Yang, MD, PhD Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

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Responsible Party: Yi Yang, Associated Dean of First Hospital of Jilin University, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT03484936     History of Changes
Other Study ID Numbers: SERIC-sICH
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yi Yang, First Hospital of Jilin University:
Intracranial Hemorrhages
remote ischemic conditioning

Additional relevant MeSH terms:
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Hemorrhage
Cerebral Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases