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Preconditioning for Aneurismal Subarachnoid Hemorrhage

Primary Purpose

Subarachnoid Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
remote limb preconditioning
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring limb preconditioning, remote preconditioning, ischemic preconditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: aneurismal subarachnoid hemorrhage

Exclusion Criteria:

  1. Hunt Hess Scale > 4
  2. Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort.
  3. Inability to obtain informed consent from the patient or a health care proxy.
  4. Ankle-brachial index < 0.7
  5. Inability to start limb preconditioning within 4 days of bleeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    remote limb preconditioning

    Arm Description

    Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.

    Outcomes

    Primary Outcome Measures

    Number of Patients With Deep Vein Thrombosis for Safety Assessment.
    Visual Analog Scale Score as a Measure of Tolerability
    The visual analogue scale is a pain scale from 0-10, with 10 being maximum pain and is frequently used in research studies assessing patient discomfort.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 21, 2010
    Last Updated
    May 5, 2017
    Sponsor
    University of Miami
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01110239
    Brief Title
    Preconditioning for Aneurismal Subarachnoid Hemorrhage
    Official Title
    Remote Ischemic Preconditioning to Ameliorate Delayed Ischemic Neurological Deficit After Aneurismal Subarachnoid Hemorrhage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Miami

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In remote preconditioning, ischemia in one organ protects distant organs from ischemic insults. e.g. brief induced limb ischemia protects the brain from an otherwise more severe stroke. The objective of this study is to determine if remote ischemic preconditioning can be safely and effectively instituted in patients with subarachnoid hemorrhage, who are at high risk for developing disabling cerebral ischemia. The investigators will also preliminarily assess if there is evidence for neuroprotection. This will be a Phase 1b study. Additional objectives are: to determine if remote ischemic preconditioning can be safely and effectively instituted in patients with subarachnoid hemorrhage, who are at high risk for developing disabling cerebral ischemia. analogously to a dose-escalation study the investigators propose to study the safety and tolerability of increasing durations of limb ischemia until a target time of 10 minutes of limb ischemia has been reached.
    Detailed Description
    The investigators propose to study patients with subarachnoid hemorrhage, who generally have a high risk of ischemic stroke in the 2 weeks following the initial bleed, and patients with clipped or coiled aneurysm. The investigators will apply a blood pressure cuff around leg and use it to interrupt the circulation for 5-10 minutes. The investigators will repeat this for a total of 3 times every 24 to 48 hours up to 14 days. The cuff will be inflated for 5-10 minutes and then deflated for 5 minutes. There will be 3 cycles of this. The cuff will be inflated to 200mmHg. The investigators will first start with 5 minutes of cuff inflation to either the arm or leg. The investigators will determine if this is safe in at least 6 patients. The investigators will then increase the duration of cuff inflation to 7.5 minutes for another 6 patients. If no adverse events are noted the investigators will the proceed to study 10 minutes of inflation in another 6 patients. If no side effects are noted the investigators will then determine that this is well tolerated. The study will be monitored by a Data Safety Monitoring Board who will make decisions about escalating the duration of cuff inflation. If 2 or more patients develop an adverse event that is related to the procedure the investigators will stop and no longer continue at that level of cuff inflation and the previous level of cuff inflation will be determined to be the safe and tolerated level. The investigators will collect safety data on adverse events such as tolerability, local tissue trauma or deep vein thrombosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Subarachnoid Hemorrhage
    Keywords
    limb preconditioning, remote preconditioning, ischemic preconditioning

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    remote limb preconditioning
    Arm Type
    Experimental
    Arm Description
    Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
    Intervention Type
    Procedure
    Intervention Name(s)
    remote limb preconditioning
    Other Intervention Name(s)
    ischemic preconditioning
    Intervention Description
    3 cycles of up to 10 minutes leg ischemia
    Primary Outcome Measure Information:
    Title
    Number of Patients With Deep Vein Thrombosis for Safety Assessment.
    Time Frame
    90 days
    Title
    Visual Analog Scale Score as a Measure of Tolerability
    Description
    The visual analogue scale is a pain scale from 0-10, with 10 being maximum pain and is frequently used in research studies assessing patient discomfort.
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aneurismal subarachnoid hemorrhage 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.

    12. IPD Sharing Statement

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    Preconditioning for Aneurismal Subarachnoid Hemorrhage

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