Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage

Launched by YI YANG · Nov 6, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called remote ischemic conditioning (RIC) for people who have experienced a type of stroke known as spontaneous intracerebral hemorrhage, which is bleeding within the brain. The main goal is to see if RIC can help improve recovery and ensure safety for patients who have had this type of stroke. The study is currently looking for participants aged 18 and older who meet certain criteria, such as having a specific type of brain bleed confirmed by a CT scan and being able to start treatment within 24 hours of the onset of symptoms.

If you or someone you know is considering participation, it’s important to know that participants will need to provide informed consent and meet specific health requirements to ensure their safety during the study. Participants will receive RIC treatment, which involves using a device on the arm to improve blood flow and potentially help the brain heal. The trial is designed to monitor how effective this treatment is and whether it is safe for those involved. If you have questions about whether you or a loved one might qualify, it’s a good idea to talk with a healthcare provider.

Gender

ALL

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.