Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage (PreLIMBS)

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

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

Study Overview

• Status: Completed
• Conditions: Ischemic Preconditioning
• Intervention / Treatment: Other: ischemic conditioning group

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: control; 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; 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; Other Names: limb preconditioning
ACTIVE_COMPARATOR: treatment group; 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; 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; Other Names: limb preconditioning

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome - number of patients with a good modified Rankin Scale, defined as less than 2	The number of patients with a good modified Rankin Scale, defined as less than 2, in the control and intervention group.	90 days

Collaborators and Investigators

• Sponsor: University of Miami

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2008
• Primary Completion (ACTUAL): December 8, 2020
• Study Completion (ACTUAL): December 8, 2020

Study Registration Dates

• First Submitted: March 30, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (ESTIMATE): April 8, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Ischemia; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: 2008 0406 II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No