Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage (PreLIMBS)

University of Miami

Status: Completed

Conditions: Ischemic Preconditioning

Treatments: Other: ischemic conditioning group

Study type: Interventional

Funder types: Other

Identifiers

NCT02411266

2008 0406 II

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

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:

Other: ischemic conditioning group

treatment group

Active Comparator group

Description:

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.

Treatment:

Other: ischemic conditioning group