Back to resultsPreconditioning With Limb Ischemia for Subarachnoid Hemorrhage (PreLIMBS)
Primary Purpose
Ischemic Preconditioning
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ischemic conditioning group
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Preconditioning
Eligibility 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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
control
treatment group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Safety Outcome 2 - number of patients who develop neurovascular injury
The number of patients who develop neurovascular injury in the treatment and control group.
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.
Safety Outcome 4 - number of patients with cardiovascular events
The number of patients with cardiovascular events [defined as hypotension, myocardial ischemia]
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02411266
Brief Title
Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage
Acronym
PreLIMBS
Official Title
Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurysmal Subarachnoid Hemorrhage: a Safety and Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 30, 2008 (Actual)
Primary Completion Date
December 8, 2020 (Actual)
Study Completion Date
December 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to learn about protecting the brain from dangerous low blood flow.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Preconditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm 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.
Arm Title
treatment group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
ischemic conditioning group
Other Intervention Name(s)
limb preconditioning
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety Outcomes 1 - number of patients who develop deep vein thrombosis and thromboembolism
Description
The number of patients who develop deep vein thrombosis and thromboembolism in the treatment and control group.
Time Frame
90 days
Title
Safety Outcome 2 - number of patients who develop neurovascular injury
Description
The number of patients who develop neurovascular injury in the treatment and control group.
Time Frame
90 days
Title
Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort
Description
The number of patients who cannot tolerate the intervention due to discomfort.
Time Frame
90 days
Title
Safety Outcome 4 - number of patients with cardiovascular events
Description
The number of patients with cardiovascular events [defined as hypotension, myocardial ischemia]
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Clinical Outcome - number of patients with a good modified Rankin Scale, defined as less than 2
Description
The number of patients with a good modified Rankin Scale, defined as less than 2, in the control and intervention group.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Koch, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage
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