Intracranial Hemorrhages
Conditions
Keywords
Intracranial Hemorrhage, remote ischemic conditioning
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.
Interventions
DEVICERemote 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.
DEVICESham 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.
Sponsors
Yi Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Supratentorial intracerebral hemorrhage confirmed by brain CT scan. 3. No disability in the community before ICH (premorbid mRS≤ 1). 4. NIHSS score ≥ 6 and GCS ≥ 8 upon presentation. 5. Able to commence RIC treatment within 24 hours of stroke onset. 6. Systolic blood pressure ≤ 180 mmHg before randomization. 7. Signed and dated informed consent is obtained.
Exclusion criteria
1. Definite evidence of secondary ICH, such as structural abnormality, brain aneurysm, brain tumor, thrombolytic drug. 2. Hematoma with a mid-line shift, cerebral herniation or isolate intraventricular hemorrhage. 3. Already booked for surgical treatment. 4. Life expectancy of less than 180 days due to comorbid conditions. 5. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban or coagulopathy (defined as INR, APTT, and PT beyond the upper limit of normal range). 6. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC. 7. Severe hepatic and renal dysfunction, or ALT/AST \>3 times upper limit of normal, or serum creatinine \>265umol/l. 8. Known pregnancy or breastfeeding. 9. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial. 10. A high likelihood that the patient will not adhere to the study treatment and follow up regimen. 11. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 180 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days | 90 days | Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome. |
| Ordinal shift of the full range of mRS scores at 90 and 180 days | 90 days, 180 days | Ranged from 0 to 6, a low value represents a better outcome. |
| Hematoma growth at 24 hours | 24 hours | The growth in hematoma volume after the onset of intracerebral hemorrhage, which is assessed by Computed Tomography (CT) brain scan. |
| National Institute of Health stroke scale (NIHSS) at 7 days | 7 days | National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome. |
| Adverse events occurring in the course of the study. | 6 months | The safety endpoints will include all adverse events, severe adverse events and RIC related adverse events. |
Countries
China
Contacts
Primary ContactYi Yang, MD, PhD
Backup ContactZhenni Guo, MD, PhD
Outcome results
None listed