Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage

NCT ID: NCT05609110

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2025-05-01

Brief Summary

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in treating acute intracerebral hemorrhage.

Detailed Description

Spontaneous intracerebral hemorrhage is a major cause of disability and mortality among different types of stroke, and few effective treatment options are available. Therefore, it is essential to develop new approaches to improve the prognosis of these patients. Recently, remote ischemic conditioning (RIC), a method that involves inducing multiple brief episodes of ischemia and reperfusion in the limbs, has been indicated to exert neuroprotective effects in experimental stroke. The underlying neuroprotective mechanism triggered by RIC induces gene expression, alters pathways, promotes neurogenesis and blood vessel development, reduces oxidative stress and neuronal apoptosis, and inhibits proinflammatory signals. Previously, several clinical trials have shown that single or repeated RIC treatments for cerebrovascular diseases are feasible and safe. Therefore, we hypothesize that RIC could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled trial to evaluate the efficacy and safety of RIC in treating intracerebral hemorrhage.

Conditions

Intracranial Hemorrhages

Study Design

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

Study Groups

RIC group

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 mmHg.

Group Type: ACTIVE_COMPARATOR

Remote ischemic conditioning

Intervention Type: DEVICE

Remote ischemic conditioning 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 mmHg.

Sham RIC group

Sham remote ischemic conditioning (Sham RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.

Group Type: PLACEBO_COMPARATOR

Sham remote ischemic conditioning

Intervention Type: DEVICE

Remote ischemic conditioning 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 60 mmHg.

Interventions

Remote ischemic conditioning

Remote ischemic conditioning 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 mmHg.

Intervention Type: DEVICE

Sham remote ischemic conditioning

Remote ischemic conditioning 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 60 mmHg.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years.

2. Supratentorial intracerebral hemorrhage confirmed by brain CT scan.

3. No disability in the community before ICH (premorbid mRS≤ 1).

4. NIHSS score ≥ 6 and GCS ≥ 8 upon presentation.

5. Able to commence RIC treatment within 24 hours of stroke onset.

6. Systolic blood pressure ≤ 180 mmHg before randomization.

7. Signed and dated informed consent is obtained.

Exclusion Criteria

1. Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, thrombolytic drug.

2. Hematoma with a mid-line shift, cerebral herniation or isolate intraventricular hemorrhage.

3. Already booked for surgical treatment.

4. Life expectancy of less than 180 days due to comorbid conditions.

5. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban or coagulopathy (defined as INR, APTT, and PT beyond the upper limit of normal range).

6. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC.

7. Severe hepatic and renal dysfunction, or ALT/AST >3 times upper limit of normal, or serum creatinine >265umol/l.

8. Known pregnancy or breastfeeding.

9. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.

10. A high likelihood that the patient will not adhere to the study treatment and follow up regimen.

11. 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

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Yang, MD, PhD

Role: CONTACT

doctoryangyi@163.com

13756661217 ext. 0086

Zhenni Guo, MD, PhD

Role: CONTACT

zhen1ni2@163.com

18186872986 ext. 0086

Facility Contacts

Yi Yang, MD, PhD

Role: primary

doctoryangyi@163.com

+86-18186870008

Other Identifiers

SERIC-ICH

Identifier Type: -

Identifier Source: org_study_id