Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage

NCT02411266 | Completed

• 1 other identifier: 2008 0406 II
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Preconditioning

Outcome Measures

Primary Outcomes (4)

• 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

Other Outcomes (1)

• Clinical Outcome - number of patients with a good modified Rankin Scale, defined as less than 2

  90 days

Study Arms (2)

control

PLACEBO COMPARATOR

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

treatment group

ACTIVE COMPARATOR

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

Interventions

ischemic conditioning group OTHER

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

Also known as: limb preconditioning

control; treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

• Sebastian Koch, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Neurology

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 8, 2015
• Study Start: July 30, 2008
• Primary Completion: December 8, 2020
• Study Completion: December 8, 2020
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)