Back to resultsSafety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage
Primary Purpose
Intracranial Hemorrhages
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sham remote ischemic conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Hemorrhages focused on measuring Intracranial Hemorrhage, remote ischemic conditioning
Eligibility Criteria
Inclusion Criteria: Age 18-80 years. Supratentorial intracerebral hemorrhage confirmed by brain CT scan. Pre-ICH mRS ≤ 1. NIHSS score ≥ 4 and GCS ≥ 8 upon presentation. Able to commence RIC treatment within 24 hours of stroke onset. Systolic blood pressure ≤ 180 mmHg. 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. Hematoma with a mid-line shift, cerebral hernia or isolate intraventricular hemorrhage. Already booked for surgical treatment. Life expectancy of less than 90 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.
Sites / Locations
- First Hospital of Jilin UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
RIC group
Sham RIC group
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 mmHg.
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.
Outcomes
Primary Outcome Measures
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 3 months
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
Secondary Outcome Measures
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1 at 3 months
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1. Ranged from 0 to 6, a low value represents a better outcome.
Proportion of patients with Modified Rankin Scale (mRS) Score 0-3 at 3 months
Proportion of patients with Modified Rankin Scale (mRS) Score 0-3. Ranged from 0 to 6, a low value represents a better outcome.
Hematoma growth at 24 hours and 7 days
The proportional growth in hematoma volume after the onset of intracerebral hemorrhage, which is assessed by Computed Tomography (CT) brain scan.
Adverse events within 3 months
The safety endpoints will include all adverse events and severe adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05609110
Brief Title
Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage
Official Title
Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
May 1, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hemorrhages
Keywords
Intracranial Hemorrhage, remote ischemic conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RIC group
Arm Type
Active Comparator
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 mmHg.
Arm Title
Sham RIC group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
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
Intervention Name(s)
Sham remote ischemic conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 3 months
Description
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1 at 3 months
Description
Proportion of patients with Modified Rankin Scale (mRS) Score 0-1. Ranged from 0 to 6, a low value represents a better outcome.
Time Frame
3 months
Title
Proportion of patients with Modified Rankin Scale (mRS) Score 0-3 at 3 months
Description
Proportion of patients with Modified Rankin Scale (mRS) Score 0-3. Ranged from 0 to 6, a low value represents a better outcome.
Time Frame
3 months
Title
Hematoma growth at 24 hours and 7 days
Description
The proportional growth in hematoma volume after the onset of intracerebral hemorrhage, which is assessed by Computed Tomography (CT) brain scan.
Time Frame
0-7 days
Title
Adverse events within 3 months
Description
The safety endpoints will include all adverse events and severe adverse events.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Intracerebral hematoma volume at 7 days
Description
Intracerebral hematoma volume is assessed by Computed Tomography (CT) brain scan.
Time Frame
0-7 days
Title
Hematoma absorption at 7 days
Description
Hematoma absorption is assessed by Computed Tomography (CT) brain scan.
Time Frame
0-7 days
Title
National Institute of Health stroke scale (NIHSS) at 7 days
Description
National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
Time Frame
0-7 days
Title
Glasgow Coma Scale (GCS) at 7 days
Description
Glasgow Coma Scale (GCS) ranged from 3 to 15, a high value represents a better outcome.
Time Frame
0-7 days
Title
Hematological indicators at 7 days
Description
The changes of hematological indicators.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-80 years.
Supratentorial intracerebral hemorrhage confirmed by brain CT scan.
Pre-ICH mRS ≤ 1.
NIHSS score ≥ 4 and GCS ≥ 8 upon presentation.
Able to commence RIC treatment within 24 hours of stroke onset.
Systolic blood pressure ≤ 180 mmHg.
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.
Hematoma with a mid-line shift, cerebral hernia or isolate intraventricular hemorrhage.
Already booked for surgical treatment.
Life expectancy of less than 90 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yang, MD, PhD
Phone
13756661217
Ext
0086
Email
doctoryangyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenni Guo, MD, PhD
Phone
18186872986
Ext
0086
Email
zhen1ni2@163.com
Facility Information:
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang, MD, PhD
Phone
+86-18186870008
Email
doctoryangyi@163.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage
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