Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurysmal Subarachnoid Hemorrhage: a Safety and Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Preconditioning
- Sponsor
- University of Miami
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to learn about protecting the brain from dangerous low blood flow.
Investigators
Sebastian Koch
Associate Professor of Clinical Neurology
University of Miami
Eligibility Criteria
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.
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
Outcomes
Primary Outcomes
Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 90 days
The number of patients with cardiovascular events \[defined as hypotension, myocardial ischemia\]