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RecruitingNCT00552357Updated Jul 22, 2026

Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation

An observational study in Primary Graft Dysfunction and Lung Transplantation, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 13 Years to 68 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by University of Pennsylvania · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,150
Ages
13 Years to 68 Years
Sex
All
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Study summary

Primary graft dysfunction (PGD) is a severe lung complication that can occur in the days after lung transplant surgery. This study will analyze blood samples to determine if high levels of certain chemicals may increase the risk of developing PGD after a lung transplant.

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 PGD is often expensive, and it is the leading cause of death following lung transplantation. Many potential lung donors and recipients are considered unsuitable for lung transplantation because of concern for the development of PGD. Increased levels of chemicals that are involved in bleeding and clotting, including protein C, and certain markers of oxidant stress, which can cause damage to the body's cells and tissues, may increase a person's risk of developing complications following a lung transplant. The purpose of this study is to analyze blood samples to determine if elevated levels of certain chemicals may be associated with an increased risk of developing PGD after lung transplantation.

This study will enroll individuals who are undergoing lung or heart and lung transplantation. Blood samples will be collected from participants prior to surgery, immediately following surgery, and 24 hours after surgery. Study researchers will also review participants' medical records. There will be no additional study visits.

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Conditions studied

  • Primary Graft Dysfunction
  • Lung Transplantation
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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
13 Years to 68 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

People undergoing lung transplantation

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 or combined heart and lung transplantation

Exclusion criteria

Exclusion Criteria:

  • Undergoing combined organ transplantation other than heart and lung transplantation
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,150 participants (estimated)
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Primary graft dysfunction, defined by the ISHLT criteria

    Time frame: Measured within 72 hours following transplantation

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Diamond JM, Cantu E, Calfee CS, Anderson MR, Clausen ES, Shashaty MGS, Courtwright AM, Kalman L, Oyster M, Crespo MM, Bermudez CA, Benvenuto L, Palmer SM, Snyder LD, Hartwig MG, Todd JL, Wille K, Hage C, McDyer JF, Merlo CA, Shah PD, Orens JB, Dhillon GS, Weinacker AB, Lama VN, Patel MG, Singer JP, Hsu J, Localio AR, Christie JD. The Impact of Donor Smoking on Primary Graft Dysfunction and Mortality after Lung Transplantation. Am J Respir Crit Care Med. 2024 Jan 1;209(1):91-100. doi: 10.1164/rccm.202303-0358OC. PubMed 37734031 ↗
  • Diamond JM, Lee JC, Kawut SM, Shah RJ, Localio AR, Bellamy SL, Lederer DJ, Cantu E, Kohl BA, Lama VN, Bhorade SM, Crespo M, Demissie E, Sonett J, Wille K, Orens J, Shah AS, Weinacker A, Arcasoy S, Shah PD, Wilkes DS, Ware LB, Palmer SM, Christie JD; Lung Transplant Outcomes Group. Clinical risk factors for primary graft dysfunction after lung transplantation. Am J Respir Crit Care Med. 2013 Mar 1;187(5):527-34. doi: 10.1164/rccm.201210-1865OC. Epub 2013 Jan 10. PubMed 23306540 ↗
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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
NCT00552357
Responsible party
Sponsor
First posted
Nov 1, 2007
Start date
Dec 2007
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jul 22, 2026

Study contacts

E.J. Demissie, MSN
Contact
215-573-4767
Jason D. Christie, MD
principal investigator · University of Pennsylvania

Oversight

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

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