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

NCT03484936 | Not Yet Recruiting DMC

• 1 other identifier: SERIC-sICH
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Hemorrhages

Keywords

Intracranial Hemorrhages; remote ischemic conditioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of adverse events

  3 months

Other Outcomes (3)

• Proportion of hematoma growth

  24 hours

• Proportion of hematoma absorption

  14 days

• Changes of hematological indicators

  24 hours; 7 days

Study Arms (2)

RIC+Standard medical treatment

ACTIVE COMPARATOR

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

Sham RIC+Standard medical treatment

PLACEBO COMPARATOR

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

Interventions

Remote ischemic conditioning 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.

Also known as: RIC

RIC+Standard medical treatment

Sham remote ischemic conditioning PROCEDURE

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

Also known as: Sham RIC

Sham RIC+Standard medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Supratentorial intracerebral hemorrhage confirmed by brain CT scan
• Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
• NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
• Able to commence RIC treatment within 12 hours of stroke onset
• Signed and dated informed consent is obtained.

You may not qualify if:

• Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
• A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
• Already booked for surgical treatment
• Life expectancy of less than 90 days due to comorbid conditions
• Severe hematologic disease
• Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban.
• Concurrent use of glibenclamide or nicorandil
• Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC
• Severe hepatic and renal dysfunction
• Platelet count \<100×10\^9/L
• Coagulopathy defined as INR,APTT,and PT beyond the upper limit of normal range
• Known pregnancy, or positive pregnancy test, or breastfeeding
• Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial
• A high likelihood that the patient will not adhere to the study treatment and follow up regimen
• Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Yang, MD, PhD

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

  STUDY CHAIR

Central Study Contacts

Yi Yang, MD, PhD

CONTACT

0086-13756661217; doctor_yangyi@163.com

Zhenni Guo, MD

CONTACT

zhen1ni2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Dean of First Hospital of Jilin University

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: April 2, 2018
• Study Start: March 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): June 15, 2027
• Last Updated: October 2, 2024

Record last verified: 2024-02

Locations

CN (1)