Clinical trial NCT05609110: 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
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Hemorrhages
Keywords: Intracranial Hemorrhage
remote ischemic conditioning
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 180 days
timeFrame: 180 days
Secondary outcomes:
measure: Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
timeFrame: 90 days
measure: Ordinal shift of the full range of mRS scores at 90 and 180 days
timeFrame: 90 days, 180 days
measure: Hematoma growth at 24 hours
timeFrame: 24 hours
measure: National Institute of Health stroke scale (NIHSS) at 7 days
timeFrame: 7 days
measure: Adverse events occurring in the course of the study.
timeFrame: 6 months
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References: