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NCT Number: NCT00552357

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

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.

Recruiting

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Key information

Age range

13 year–68 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing lung or combined heart and lung transplantation

Exclusion criteria

  • Undergoing combined organ transplantation other than heart and lung transplantation

Treatment and study plan

Primary outcomes

  1. Primary graft dysfunction, defined by the ISHLT criteria

    Time frame: Measured within 72 hours following transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

E.J. Demissie, MSN

CONTACT

215-573-4767

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Columbia University
  • Duke University
  • Johns Hopkins University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Stanford University
  • University of Alabama at Birmingham
  • University of Chicago
  • University of Michigan
  • University of Pittsburgh
  • Vanderbilt University

Registry information

Official study title

Clinical Risk Factors for Primary Graft Dysfunction

Important dates

Study start
2007
Primary completion
2027
Study completion
2027
First posted
Nov 1, 2007
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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