NCT03484936

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 530 (estimated)
• Sponsor: Yi Yang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Intracranial Hemorrhages

Interventions

Type	Name	Description
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.
PROCEDURE	Sham remote ischemic conditioning	Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-09-15
• Completion: 2027-06-15
• First posted: 2018-04-02
• Last updated: 2024-10-02

Locations

1 site across 1 country: China