Using remote ischemic conditioning to treat spontaneous intracerebral hemorrhage

Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage

This study is testing if a new treatment called remote ischemic conditioning can help people who have had a brain bleed recover better when started soon after their stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT05609110 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of remote ischemic conditioning (RIC) as a treatment for acute spontaneous intracerebral hemorrhage. RIC involves inducing brief episodes of ischemia and reperfusion in the limbs, which may provide neuroprotective effects and improve patient outcomes. The trial is designed as a prospective, multicenter, randomized controlled trial, enrolling patients who meet specific criteria and can begin treatment within 24 hours of stroke onset. The study will compare the effects of RIC against a sham treatment to assess its potential benefits in improving functional outcomes for patients with this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with confirmed supratentorial intracerebral hemorrhage and no prior disability.

Not a fit: Patients with secondary intracerebral hemorrhage, significant comorbid conditions, or those requiring immediate surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery and reduce disability in patients suffering from spontaneous intracerebral hemorrhage.

How similar studies have performed: Previous clinical trials have indicated that remote ischemic conditioning is feasible and safe for cerebrovascular diseases, suggesting potential for success in this novel application.

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.

Where this trial is running

Changchun, Jilin

• First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Yi Yang, MD, PhD

Conditions Intracranial Hemorrhages; Intracranial Hemorrhage; remote ischemic conditioning