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

NCT ID: NCT03484936

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 530 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-15
• Study Completion Date: 2027-06-15

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.

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.

Conditions

Intracranial Hemorrhages

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Remote ischemic conditioning

Intervention Type: PROCEDURE

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 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.

Group Type: PLACEBO_COMPARATOR

Sham remote ischemic conditioning

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Sham remote ischemic conditioning

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

Intervention Type: PROCEDURE

Other Intervention Names

RIC; Sham RIC

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Yang

OTHER

Sponsor Role: lead

Responsible Party

Yi Yang

Associated Dean of First Hospital of Jilin University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yi Yang, MD, PhD

Role: STUDY_CHAIR

Neuroscience Center, Department of Neurology, The First Hospital of Jilin University

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Central Contacts

Yi Yang, MD, PhD

Role: CONTACT

doctor_yangyi@163.com

0086-13756661217

Zhenni Guo, MD

Role: CONTACT

zhen1ni2@163.com

Facility Contacts

Yi Yang, MD, PhD

Role: primary

doctor_yangyi@163.com

Other Identifiers

SERIC-sICH

Identifier Type: -

Identifier Source: org_study_id