Miami, Florida 33136


Purpose:

In remote preconditioning, ischemia in one organ protects distant organs from ischemic insults. e.g. brief induced limb ischemia protects the brain from an otherwise more severe stroke. The investigators propose a study of limb preconditioning in subjects with subarachnoid hemorrhage who are at high risk of cerebral ischemia in the first 2 weeks after hemorrhage. The investigators have previously shown that 3x 10min leg conditioning cycles are tolerated and appear safe. The investigators are now continuing to assess the safety of the intervention by enrolling an additional 60 patients.


Study summary:

The study will enroll patients with subarachnoid hemorrhage, who generally have a high risk of ischemic stroke in the 2 weeks following the initial bleed, and patients with clipped or coiled aneurysm. The study intervention will consist of the application a blood pressure cuff around the subjects arm or leg and use it to interrupt the circulation to the arm or leg for 10 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. The primary endpoints are safety in nature and defined as follows: 1. If the prolonged upper or lower extremity application of blood pressure cuff should induce tissue breakdown, ischemic injury or musculoskeletal injury patient will be withdrawn from the study. 2. If the subject does not wish to continue with limb preconditioning because of discomfort or pain. 3. Any unexplained neurological deterioration will be carefully reviewed and the etiology ascertained. If this should temporally coincide with the preconditioning stimulus on at least 2 occasions the patient will be withdrawn from the study. 4. Any unexplained cardiovascular event (myocardial ischemia, chest pain, hypotension) will be carefully monitored and the etiology reviewed. Any temporal association with the pre-conditioning protocol will be examined. 5. Deep vein thrombosis. Patients with subarachnoid hemorrhage have a high incidence of deep vein thrombosis. It will be difficult to determine if this is due to the intervention or not. The investigators will carefully monitor deep vein thrombosis in the preconditioned leg and compare that to the incidence in the non-preconditioned leg. The Data Safety Monitoring Board (DSMB) will make final adjudication of the relation of preconditioning procedure and development of deep vein thrombosis.


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


NCT ID:

NCT02411266


Primary Contact:

Principal Investigator
Sebastian Koch, MD
University of Miami

Sebastian Koch, MD
Phone: 3052436732
Email: skoch@miami.edu


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States

Sebastian Koch, MD
Phone: 305-243-6732
Email: skoch@miami.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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