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

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
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
NCT ID
NCT00284726
First Posted
January 31, 2006
Last Updated
September 26, 2023
Sponsor
Johns Hopkins University
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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