CLAD Phenotype Specific Risk Factors and Mechanisms (NCT02631720) | Clinical Trial Compass
CompletedNot Applicable
CLAD Phenotype Specific Risk Factors and Mechanisms
United States, Canada884 participantsStarted 2015-12-22
Plain-language summary
While many patients experience benefits from transplant, complications such as infections and lung rejection may affect long term survival and quality of life. In this study doctors are looking at a complication called Chronic Lung Allograft Dysfunction (CLAD). CLAD is thought to be chronic rejection of the lung by the immune system and is the leading cause of death after lung transplantation.
The purpose of this study is to help doctors determine:
* why some people get CLAD and others do not
* how patients who get CLAD do after CLAD is diagnosed
* how CLAD may affect quality of life
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Subject must be able to understand and provide written informed consent and
āMust be ā„18 years of age at the time of written informed consent.
ā. Anticipated listing for lung transplantation OR within 45 days of having received a single or bilateral cadaveric donor lung transplant.
ā. Undergoing first lung transplant operation.
ā. Transplant surgery to be performed or performed at enrolling center.
Exclusion criteria
ā. Multi-organ recipient.
ā. Prior recipients of any solid organ transplant, including prior lung transplant.
ā. Prior or concurrent recipient of bone marrow transplant.
ā. HIV infection.
ā. Any condition which the investigators feel would make it unlikely for the recipient to complete follow up procedures or complete the study.
What they're measuring
1
Time from transplant to Restrictive Chronic Lung Allograft Dysfunction (RCLAD) or Bronchiolitis Obliterans Syndrome (BOS).
Timeframe: 90 days post-transplant until study completion or participant withdrawal (up to 4 years post-transplant)
Trial details
NCT IDNCT02631720
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)