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

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 Overview

• Status: Not yet recruiting
• Conditions: Intracranial Hemorrhages
• Intervention / Treatment: Procedure: Remote ischemic conditioning; Procedure: Sham remote ischemic conditioning

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.

• Study Type: Interventional
• Enrollment (Estimated): 530
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Yang, MD, PhD; Phone Number: 0086-13756661217; Email: doctor_yangyi@163.com
• Study Contact Backup: Name: Zhenni Guo, MD; Email: zhen1ni2@163.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • First Hospital of Jilin University
      • Contact: Yi Yang, MD, PhD; Email: doctor_yangyi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Sham RIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events	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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of hematoma growth	The proportional growth in hematoma volume during the first 24h after the onset of intracerebral hemorrhage.	24 hours
Proportion of hematoma absorption	The proportional change in hematoma volume between 24h and 14 days or discharge (whichever is earlier) after the onset of intracerebral hemorrhage.	14 days
Changes of hematological indicators	The changes of hematological indicators (inflammatory cytokine,et al.) during the first 24h and 7 days after the onset of intracerebral hemorrhage.	24 hours; 7 days

Collaborators and Investigators

• Sponsor: Yi Yang
• Investigators: Study Chair: Yi Yang, MD, PhD, Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: remote ischemic conditioning; Intracranial Hemorrhages
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Intracranial Hemorrhages; Cerebral Hemorrhage
• Other Study ID Numbers: SERIC-sICH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No