Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage

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

Official Title
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Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurysmal Subarachnoid Hemorrhage: a Safety and Feasibility Study

Conditions
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Ischemic Preconditioning

Intervention / Treatment
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* Other: ischemic conditioning group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>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. | Other: ischemic conditioning group<br>* application of a blood pressure cuff around a leg and inflating the cuff to 200mmHg to induce limb ischemia for 10min followed by 5min reperfusion. this will be done for 3 cycles every 24-48hours during the first 14 days after subarachnoid hemorrhage<br>* Other names: limb preconditioning;|
| Active Comparator: treatment group<br>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. | Other: ischemic conditioning group<br>* application of a blood pressure cuff around a leg and inflating the cuff to 200mmHg to induce limb ischemia for 10min followed by 5min reperfusion. this will be done for 3 cycles every 24-48hours during the first 14 days after subarachnoid hemorrhage<br>* Other names: limb preconditioning;|

What is the study measuring?
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Primary Outcome Measures

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