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

Primary Purpose

Intracranial Hemorrhages

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Remote ischemic conditioning

Sham remote ischemic conditioning

About this trial

This is an interventional treatment trial for Intracranial Hemorrhages focused on measuring Intracranial Hemorrhages, remote ischemic conditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

RIC+Standard medical treatment

Sham RIC+Standard medical treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03484936

First Posted

March 25, 2018

Last Updated

October 31, 2022

Sponsor

Yi Yang

1. Study Identification

Unique Protocol Identification Number

NCT03484936

Brief Title

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

Acronym

SERIC-sICH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 15, 2023 (Anticipated)

Primary Completion Date

September 15, 2024 (Anticipated)

Study Completion Date

June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yi Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracranial Hemorrhages

Keywords

Intracranial Hemorrhages, remote ischemic conditioning

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RIC+Standard medical treatment

Arm Type

Active Comparator

Arm Description

Arm Title

Sham RIC+Standard medical treatment

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Remote ischemic conditioning

Other Intervention Name(s)

RIC

Intervention Description

Intervention Type

Procedure

Intervention Name(s)

Sham remote ischemic conditioning

Other Intervention Name(s)

Sham RIC

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of patients with Modified Rankin Scale (mRS) Score 0-2

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Frequency of adverse events

Description

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.

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Proportion of hematoma growth

Description

The proportional growth in hematoma volume during the first 24h after the onset of intracerebral hemorrhage.

Time Frame

24 hours

Title

Proportion of hematoma absorption

Description

The proportional change in hematoma volume between 24h and 14 days or discharge (whichever is earlier) after the onset of intracerebral hemorrhage.

Time Frame

14 days

Title

Changes of hematological indicators

Description

The changes of hematological indicators (inflammatory cytokine,et al.) during the first 24h and 7 days after the onset of intracerebral hemorrhage.

Time Frame

24 hours; 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Yang, MD, PhD

Phone

0086-13756661217

doctor_yangyi@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhenni Guo, MD

zhen1ni2@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi Yang, MD, PhD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

First Hospital of Jilin University

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yi Yang, MD, PhD

doctor_yangyi@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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