Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Device: 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.
|
| Placebo Comparator: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 3 months [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 [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 [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 [0-7 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 [3 months]
The safety endpoints will include all adverse events and severe adverse events.
Other Outcome Measures
- Intracerebral hematoma volume at 7 days [0-7 days]
Intracerebral hematoma volume is assessed by Computed Tomography (CT) brain scan.
- Hematoma absorption at 7 days [0-7 days]
Hematoma absorption is assessed by Computed Tomography (CT) brain scan.
- National Institute of Health stroke scale (NIHSS) at 7 days [0-7 days]
National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
- Glasgow Coma Scale (GCS) at 7 days [0-7 days]
Glasgow Coma Scale (GCS) ranged from 3 to 15, a high value represents a better outcome.
- Hematological indicators at 7 days [7 days]
The changes of hematological indicators.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Hospital of Jilin University | Changchun | Jilin | China | 130000 |
Sponsors and Collaborators
- Yi Yang
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SERIC-ICH