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

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ClinicalTrials.gov Identifier: NCT00284726

Recruitment Status : Completed

First Posted : February 1, 2006

Last Update Posted : December 7, 2017

Sponsor:

Information provided by:

Johns Hopkins University

Tracking Information

First Submitted Date ^ICMJE

January 31, 2006

First Posted Date ^ICMJE

February 1, 2006

Last Update Posted Date

December 7, 2017

Study Start Date ^ICMJE

December 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Lung Transplant Recipients

Intervention ^ICMJE

Device: Celsior Cold Storage Solution

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Original Enrollment ^ICMJE

Not Provided

Study Completion Date ^ICMJE

September 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Any patient undergoing a lung trasnplant at Johns Hopkins Hospital -

Exclusion Criteria:

Sex/Gender ^ICMJE

Not Provided

Ages ^ICMJE

Child, Adult, Older Adult

Accepts Healthy Volunteers ^ICMJE

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00284726

Other Study ID Numbers ^ICMJE

00-10-25-03

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

John V. Conte, M.D.

Johns Hopkins University

PRS Account

Johns Hopkins University

Verification Date

December 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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