Primary Graft DysfunctionNCT00457847
Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation
An observational study of Primary Graft Dysfunction and Lung Transplantation, run by University of Pennsylvania at 1 site in United States.
Trial summary
Primary graft dysfunction (PGD) is a severe lung injury that can occur in the days following lung transplant surgery. The purpose of this study is to identify genetic factors that may put someone at risk for developing PGD. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Primary Graft Dysfunction, Lung Transplantation
- How many people
- 1,150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients going under lung transplant or heart \& lung transplants
Who may be able to join
- Undergoing lung transplant surgery
Who cannot join
- Individuals undergoing multi-organ transplantation except heart/lung transplants
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Genetics of Primary Graft Dysfunction
Primary graft dysfunction (PGD) is a severe lung injury that can occur in the days following lung transplant surgery. The purpose of this study is to identify genetic factors that may put someone at risk for developing PGD.
Read the detailed description
PGD is a severe complication that affects up to 25% of lung transplant patients following surgery. Pulmonary edema, which is an abnormal build-up of fluid in the lungs, and hypoxemia, which is low blood oxygen levels, are two common symptoms that individuals with PGD experience. Treatment for this condition is often expensive, and it is the leading cause of death following lung transplant. Many potential donors and recipients are considered unsuitable for lung transplant because of concern for the development of PGD. Therefore, the ability to accurately predict which individuals are at risk for developing PGD may allow more lung transplants to be performed. Specific characteristics in both lung donors and recipients may play an important role in determining the risk of PGD. For example, genetic variations in how the body deals with harmful chemicals called oxidants may be associated with the development of PGD. The purpose of this study is to identify the specific genetic biomarkers in donors and recipients that put individuals at risk for developing PGD following a lung transplant.
This study will enroll individuals who are undergoing lung transplantation. Blood samples will be collected from lung donors and from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will monitor participants for 72 hours following surgery for symptoms of PGD. There will be no additional study visits.
- Conditions
- Primary Graft Dysfunction, Lung Transplantation
- Keywords
- PGD
- Medical subject headings
- Primary Graft Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary graft dysfunction
ISHLT standard definition and grading system will be used
Measured: First 72 hours post lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Graft DysfunctionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Columbia University, Vanderbilt University, Stanford University, University of Alabama at Birmingham, University of Michigan, Johns Hopkins University, Duke University, University of Pittsburgh, University of Chicago
- Responsible party
- Sponsor
- Investigators
- Jason D. Christie, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457847
- Sponsor's protocol ID
- 1380
- Other IDs
- R01HL081619
- Status last verified
- Jul 2026
- First submitted
- 5 Apr 2007
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diamond JM, Akimova T, Kazi A, Shah RJ, Cantu E, Feng R, Levine MH, Kawut SM, Meyer NJ, Lee JC, Hancock WW, Aplenc R, Ware LB, Palmer SM, Bhorade S, Lama VN, Weinacker A, Orens J, Wille K, Crespo M, Lederer DJ, Arcasoy S, Demissie E, Christie JD; Lung Transplant Outcomes Group. Genetic variation in the prostaglandin E2 pathway is associated with primary graft dysfunction. Am J Respir Crit Care Med. 2014 Mar 1;189(5):567-75. doi: 10.1164/rccm.201307-1283OC.
PubMed 24467603