Safety and Efficacy of Remote Ischemic Conditioning in Patients With Spontaneous Intracerebral Hemorrhage

Launched by YI YANG · Mar 26, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment method called remote ischemic conditioning (RIC) to see if it can help patients who have experienced a type of stroke known as spontaneous intracerebral hemorrhage, which is bleeding within the brain. The aim is to gather enough information about the safety and potential benefits of RIC before deciding whether to conduct a larger study. This trial is not yet recruiting participants, but it will be open to adults aged 18 and older who have had a confirmed brain bleed and were living independently before the incident.

To be eligible for the trial, participants should have a certain level of stroke severity and be able to start the RIC treatment within 12 hours after the bleeding starts. However, there are some conditions that would exclude someone from participating, such as having a high chance of dying soon, being scheduled for surgery, or having certain health issues that could complicate treatment. If eligible, participants can expect to receive information about the treatment and its potential risks and benefits, and they will need to provide consent before joining the study.

Gender

ALL

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.