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

Intracranial Hemorrhages Clinical Trial

— SERIC-sICH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03484936
• Other study ID #: SERIC-sICH
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: June 15, 2025

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD, PhD
• Phone: 0086-13756661217
• Email: doctor_yangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 530
• Est. completion date: June 15, 2025
• Est. primary completion date: September 15, 2024
• 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. 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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhages

Intervention

Procedure:
• Remote ischemic conditioning
Remote ischemic conditioning (RIC) 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 mm Hg. RIC will be conducted twice daily for 7 days.
• Sham remote ischemic conditioning
Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.

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
Other	Proportion of hematoma growth	The proportional growth in hematoma volume during the first 24h after the onset of intracerebral hemorrhage.	24 hours
Other	Proportion of hematoma absorption	The proportional change in hematoma volume between 24h and 14 days or discharge (whichever is earlier) after the onset of intracerebral hemorrhage.	14 days
Other	Changes of hematological indicators	The changes of hematological indicators (inflammatory cytokine,et al.) during the first 24h and 7 days after the onset of intracerebral hemorrhage.	24 hours; 7 days
Primary	Proportion of patients with Modified Rankin Scale (mRS) Score 0-2	The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.	3 months
Secondary	Frequency of adverse events	The safety endpoints will include all adverse events until day-7 or discharge (whichever is earlier), and severe adverse events through day-90 after the onset of intracerebral hemorrhage.	3 months