The Effect of Cold Storage Solutions on Ischemic Injury in Lung Transplantation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Johns Hopkins University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Johns Hopkins University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00284726
First received: January 31, 2006
Last updated: NA
Last verified: August 2005
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | January 31, 2006 | ||||
| Last Updated Date | January 31, 2006 | ||||
| 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 | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Not Provided | ||||
| Condition ICMJE | Lung Transplant Recipients | ||||
| Intervention ICMJE | Device: Celsior Cold Storage Solution | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | September 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Any patient undergoing a lung trasnplant at Johns Hopkins Hospital - Exclusion Criteria: - |
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| Gender | Not Provided | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00284726 | ||||
| Other Study ID Numbers ICMJE | 00-10-25-03 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Johns Hopkins University | ||||
| Verification Date | August 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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