Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage

Not Applicable

Completed

• Conditions: Ischemic Preconditioning
• Interventions: Other: ischemic conditioning group

• Registration Number: NCT02411266
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to learn about protecting the brain from dangerous low blood flow.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2008-07-30
• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-08
• Primary Completion: 2020-12-08
• Study Completion: 2020-12-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment.
• Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate.

Read More

Exclusion Criteria

• Hunt Hess Scale > 4
• Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort.
• Inability to obtain informed consent from the patient or a health care proxy.
• Ankle-brachial index < 0.7
• Inability to start limb preconditioning within 4 days of bleeding.
• Inability to precondition a leg that is not-plegic (that is preserved anti- gravity strength) and has not been accessed for catheter angiography
• Age<18 years
• Pregnant women
• Prisoners

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	ischemic conditioning group	Subjects in this group will undergo sham preconditioning. A blood pressure cuff will be placed around the leg and inflated just lightly to a pressure of 30mmHg, not enough to affect arterial circulation. This will be maintained for 10min followed by 5min of deflation. This will constitute one conditioning cycle. There will be 3 sham conditioning cycles per treatment session.
treatment group	ischemic conditioning group	Study personnel will place a blood pressure cuff around the subject's leg and use it to interrupt the circulation to the leg for 10 minutes followed by release of the blood pressure for 5 minutes. This will be repeated for a total of 3 times every 24 to 48 hours up to 14 days. The cuff will be inflated for 10 minutes and then deflated for 5 minutes. There will be 3 cycles of this. The cuff will be inflated to 200mmHg to induce ischemia, confirmed by palpation of pedal pulses.

Primary Outcome Measures

Name	Time	Method
Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort	90 days	The number of patients who cannot tolerate the intervention due to discomfort.
Safety Outcomes 1 - number of patients who develop deep vein thrombosis and thromboembolism	90 days	The number of patients who develop deep vein thrombosis and thromboembolism in the treatment and control group.
Safety Outcome 2 - number of patients who develop neurovascular injury	90 days	The number of patients who develop neurovascular injury in the treatment and control group.
Safety Outcome 4 - number of patients with cardiovascular events	90 days	The number of patients with cardiovascular events \[defined as hypotension, myocardial ischemia\]

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States