Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage

Intracranial Hemorrhages Clinical Trial

Official title:

Safety and Efficacy of Remote Ischemic Conditioning for Spontaneous Intracerebral Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609110
• Other study ID #: SERIC-ICH
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: November 2023
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD, PhD
• Phone: 13756661217
• Email: doctoryangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in treating acute intracerebral hemorrhage.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 1, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhages

Intervention

Device:
• Remote ischemic conditioning
Remote ischemic conditioning is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mmHg.
• Sham remote ischemic conditioning
Remote ischemic conditioning is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mmHg.

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 180 days	Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.	180 days
Secondary	Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days	Proportion of patients with Modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome.	90 days
Secondary	Ordinal shift of the full range of mRS scores at 90 and 180 days	Ranged from 0 to 6, a low value represents a better outcome.	90 days, 180 days
Secondary	Hematoma growth at 24 hours	The growth in hematoma volume after the onset of intracerebral hemorrhage, which is assessed by Computed Tomography (CT) brain scan.	24 hours
Secondary	National Institute of Health stroke scale (NIHSS) at 7 days	National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.	7 days
Secondary	Adverse events occurring in the course of the study.	The safety endpoints will include all adverse events, severe adverse events and RIC related adverse events.	6 months