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Active, not recruitingNCT00457847Updated Jul 22, 2026

Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation

An observational study in Primary Graft Dysfunction and Lung Transplantation, sponsored by University of Pennsylvania. Active, not recruiting at 1 site in United States. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,150
Ages
15 Years to 65 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Primary Graft Dysfunction
  • Lung Transplantation

Keywords

  • PGD
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In context

Primary Graft Dysfunction

26 studies on the registry are indexed under Primary Graft Dysfunction; 4 are open to participants now.

This study's planned enrollment of 1,150 is above the median of 60 across 13 observational studies indexed under Primary Graft Dysfunction.

Browse Primary Graft Dysfunction studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients going under lung transplant or heart \& lung transplants

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Undergoing lung transplant surgery

Exclusion criteria

Exclusion Criteria:

- Individuals undergoing multi-organ transplantation except heart/lung transplants

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,150 participants (estimated)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Primary graft dysfunction

    ISHLT standard definition and grading system will be used

    Time frame: First 72 hours post lung transplantation

07

Study locations

1 site
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00457847
Responsible party
Sponsor
First posted
Apr 9, 2007
Start date
Feb 2007
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jul 22, 2026

Study contacts

Jason D. Christie, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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