Clinical trial NCT03484936: Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage
Official title: Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intracranial Hemorrhages
Keywords: Intracranial Hemorrhages
remote ischemic conditioning
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 530
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 whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.

Detailed description: Intracerebral hemorrhage is a devastating disease with a high rate of severe disability and death, while no specific treatment has been proven to improve functional outcome. As a result, new approaches need to be developed to treat intracerebral hemorrhage. Animal and human trials showed treatment with remote ischemic conditioning was safe for intracerebral hemorrhage. And repetitive remote ischemic conditioning has been shown to improve sensorimotor and neuropathological outcomes following experimental hemorrhagic stroke. Therefore, we hypothesize that repetitive remote ischemic conditioning could improve functional outcome in patients with intracerebral hemorrhage. We design this prospective, multicenter, randomized controlled double-blind trial to determine whether treatment with remote ischemic conditioning is of sufficient promise to improve outcome before conducting a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Supratentorial intracerebral hemorrhage confirmed by brain CT scan
3. Functional independence prior to ICH, defined as pre-ICH mRS ≤ 1
4. NIHSS score ≥ 4 and GCS ≥ 6 upon presentation
5. Able to commence RIC treatment within 12 hours of stroke onset
6. Signed and dated informed consent is obtained.

Exclusion Criteria:

1. Definite evidence of secondary ICH, such as structural abnormality, brain tumor, thrombolytic drug, and other causes
2. A very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria
3. Already booked for surgical treatment
4. Life expectancy of less than 90 days due to comorbid conditions
5. Severe hematologic disease
6. Concurrent use of anticoagulation drugs including Warfarin, dabigatran, rivaroxaban.
7. Concurrent use of glibenclamide or nicorandil
8. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in healthy upper limb which may pose a contraindication for application of RIC
9. Severe hepatic and renal dysfunction
10. Platelet count \<100×10\^9/L
11. Coagulopathy defined as INR,APTT,and PT beyond the upper limit of normal range
12. Known pregnancy, or positive pregnancy test, or breastfeeding
13. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial
14. A high likelihood that the patient will not adhere to the study treatment and follow up regimen
15. 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
timeFrame: 3 months
Secondary outcomes:
measure: Frequency of adverse events
timeFrame: 3 months
Other outcomes:
measure: Proportion of hematoma growth
timeFrame: 24 hours
measure: Proportion of hematoma absorption
timeFrame: 14 days
measure: Changes of hematological indicators
timeFrame: 24 hours; 7 days
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: Neuroscience Center, Department of Neurology, The First Hospital of Jilin University
name: Yi Yang, MD, PhD
role: STUDY_CHAIR
References: