NCT00457847

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,150

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2007

Completed
19.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

19.3 years

First QC Date

April 5, 2007

Last Update Submit

July 11, 2025

Conditions

Primary Graft DysfunctionLung Transplantation

Keywords

PGD

Outcome Measures

Primary Outcomes (1)

  • Primary graft dysfunction

    ISHLT standard definition and grading system will be used

    First 72 hours post lung transplantation

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients going under lung transplant or heart \& lung transplants

You may qualify if:

  • Undergoing lung transplant surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24467603DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Primary Graft Dysfunction

Condition Hierarchy (Ancestors)

Reperfusion InjuryVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jason D. Christie, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2007

First Posted

April 9, 2007

Study Start

February 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)