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Preconditioning With Limb Ischemia for Subarachnoid Hemorrhage (PreLIMBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02411266
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Sebastian Koch, University of Miami

Study Description
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Brief Summary:
The purpose of this study is to learn about protecting the brain from dangerous low blood flow.

Condition or disease Intervention/treatment Phase
Ischemic Preconditioning Other: ischemic conditioning group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurysmal Subarachnoid Hemorrhage: a Safety and Feasibility Study
Actual Study Start Date : July 30, 2008
Actual Primary Completion Date : December 8, 2020
Actual Study Completion Date : December 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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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 Name: 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 Name: limb preconditioning


Outcome Measures
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Primary Outcome Measures :
  1. Safety Outcomes 1 - number of patients who develop deep vein thrombosis and thromboembolism [ Time Frame: 90 days ]
    The number of patients who develop deep vein thrombosis and thromboembolism in the treatment and control group.

  2. Safety Outcome 2 - number of patients who develop neurovascular injury [ Time Frame: 90 days ]
    The number of patients who develop neurovascular injury in the treatment and control group.

  3. Safety Outcome 3 - number of patients who cannot tolerate the intervention due to discomfort [ Time Frame: 90 days ]
    The number of patients who cannot tolerate the intervention due to discomfort.

  4. Safety Outcome 4 - number of patients with cardiovascular events [ Time Frame: 90 days ]
    The number of patients with cardiovascular events [defined as hypotension, myocardial ischemia]


Other Outcome Measures:
  1. Clinical Outcome - number of patients with a good modified Rankin Scale, defined as less than 2 [ Time Frame: 90 days ]
    The number of patients with a good modified Rankin Scale, defined as less than 2, in the control and intervention group.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02411266


Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Sebastian Koch, MD University of Miami
More Information
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Responsible Party: Sebastian Koch, Associate Professor of Clinical Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT02411266    
Other Study ID Numbers: 2008 0406 II
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Ischemia
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases