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

September 26, 2023 updated by: Johns Hopkins University

A Prospective, Controlled, Randomized Study on the Effect of Cold Storage Solutions on Complement Activation and Other Mediators of Ischemic Injury in Lung Transplantation

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.

Study Overview

Status

Completed

Conditions

Lung Transplant Recipients

Intervention / Treatment

Device: Celsior Cold Storage Solution

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.

Study Type

Interventional

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

Any patient undergoing a lung trasnplant at Johns Hopkins Hospital -

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

Principal Investigator: John V. Conte, M.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimated)

February 1, 2006

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

00-10-25-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.