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The Effect of Cold Storage Solutions on Ischemic Injury in Lung Transplantation

Primary Purpose

Lung Transplant Recipients

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Celsior Cold Storage Solution
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Lung Transplant Recipients focused on measuring Cytokines in lung transplantation, Cold storage solutions, Ischemic reperfusion injury

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria: Any patient undergoing a lung trasnplant at Johns Hopkins Hospital - Exclusion Criteria: -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2006
    Last Updated
    September 26, 2023
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00284726
    Brief Title
    The Effect of Cold Storage Solutions on Ischemic Injury in Lung Transplantation
    Official Title
    A Prospective, Controlled, Randomized Study on the Effect of Cold Storage Solutions on Complement Activation and Other Mediators of Ischemic Injury in Lung Transplantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare 2 different cold storage solutions, used to preserve donor lungs for lung transplantation, and their effect on cytokine activation related to ischemic reperfusion injury. Primary endpoint is 30 day survival.
    Detailed Description
    The length of ischemic time in harvesting lung allografts is associated with graft survival. It is further thought that ischemic changes in early post-transplantation bronchoscopic biopsies has a direct correlation with later development of chronic rejection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Transplant Recipients
    Keywords
    Cytokines in lung transplantation, Cold storage solutions, Ischemic reperfusion injury

    7. Study Design

    Study Phase
    Phase 3

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Celsior Cold Storage Solution

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: Any patient undergoing a lung trasnplant at Johns Hopkins Hospital - Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John V. Conte, M.D.
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Cold Storage Solutions on Ischemic Injury in Lung Transplantation

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