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

NCT00552357 | Recruiting DMC

• 2 other identifiers: 1417R01HL087115-01A1
• Study Type: observational
• Target: 1,150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Graft Dysfunction; Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• Primary graft dysfunction, defined by the ISHLT criteria

  Measured within 72 hours following transplantation

Eligibility Criteria

• Age: 13 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People undergoing lung transplantation

You may qualify if:

• Undergoing lung or combined heart and lung transplantation

You may not qualify if:

• Undergoing combined organ transplantation other than heart and lung transplantation

Sponsors & Collaborators

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

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 37734031 DERIVED

• 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.

  PMID: 23306540 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason D. Christie, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

E.J. Demissie, MSN

CONTACT

215-573-4767

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 1, 2007
• Study Start: December 1, 2007
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)