Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage
1 other identifier
interventional
2,000
1 country
1
Brief Summary
The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in treating acute intracerebral hemorrhage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2022
CompletedFirst Posted
Study publicly available on registry
November 8, 2022
CompletedStudy Start
First participant enrolled
February 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedNovember 15, 2023
November 1, 2023
2 years
November 2, 2022
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 180 days
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
180 days
Secondary Outcomes (5)
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
90 days
Ordinal shift of the full range of mRS scores at 90 and 180 days
90 days, 180 days
Hematoma growth at 24 hours
24 hours
National Institute of Health stroke scale (NIHSS) at 7 days
7 days
Adverse events occurring in the course of the study.
6 months
Study Arms (2)
RIC group
ACTIVE COMPARATORRemote 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.
Sham RIC group
PLACEBO COMPARATORSham 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age ≥18 years.
- Supratentorial intracerebral hemorrhage confirmed by brain CT scan.
- No disability in the community before ICH (premorbid mRS≤ 1).
- NIHSS score ≥ 6 and GCS ≥ 8 upon presentation.
- Able to commence RIC treatment within 24 hours of stroke onset.
- Systolic blood pressure ≤ 180 mmHg before randomization.
- Signed and dated informed consent is obtained.
You may not qualify if:
- Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, thrombolytic drug.
- Hematoma with a mid-line shift, cerebral herniation or isolate intraventricular hemorrhage.
- Already booked for surgical treatment.
- Life expectancy of less than 180 days due to comorbid conditions.
- Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban or coagulopathy (defined as INR, APTT, and PT beyond the upper limit of normal range).
- 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, or ALT/AST \>3 times upper limit of normal, or serum creatinine \>265umol/l.
- Known pregnancy 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yi Yanglead
Study Sites (1)
First Hospital of Jilin University
Changchun, Jilin, 130000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, 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
November 2, 2022
First Posted
November 8, 2022
Study Start
February 2, 2023
Primary Completion
January 31, 2025
Study Completion
May 1, 2025
Last Updated
November 15, 2023
Record last verified: 2023-11