Primary Graft DysfunctionNCT00552357
Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
An observational study of Primary Graft Dysfunction and Lung Transplantation, run by University of Pennsylvania at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 13 to 68 years
- Conditions the study is for
- Primary Graft Dysfunction, Lung Transplantation
- How many people
- 1,150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 68 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People undergoing lung transplantation
Who may be able to join
- Undergoing lung or combined heart and lung transplantation
Who cannot join
- Undergoing combined organ transplantation other than heart and lung transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
E.J. Demissie, MSN contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Clinical Risk Factors for Primary Graft Dysfunction
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.
- Conditions
- Primary Graft Dysfunction, Lung Transplantation
- Medical subject headings
- Primary Graft Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary graft dysfunction, defined by the ISHLT criteria
Measured: Measured within 72 hours following transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startDec 2007
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Graft DysfunctionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Columbia University, University of Alabama at Birmingham, Vanderbilt University, Stanford University, Johns Hopkins University, University of Michigan, Duke University, University of Pittsburgh, University of Chicago
- Responsible party
- Sponsor
- Investigators
- Jason D. Christie, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552357
- Sponsor's protocol ID
- 1417
- Other IDs
- R01HL087115-01A1
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2007
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
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 37734031Diamond 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Risk Factors for Primary Graft Dysfunction
- ClinicalTrials.gov ID
- NCT00552357
- Acronym / sponsor ID
- 1417
- Conditions
- Primary Graft Dysfunction, Lung Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Columbia University, University of Alabama at Birmingham, Vanderbilt University, Stanford University, Johns Hopkins University, University of Michigan, Duke University, University of Pittsburgh, University of Chicago
- Study start
- Dec 2007
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People undergoing lung transplantation
Key inclusion criteria (1 listed)
- Undergoing lung or combined heart and lung transplantation
Key exclusion criteria (1 listed)
- Undergoing combined organ transplantation other than heart and lung transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary graft dysfunction, defined by the ISHLT criteria
Time frame: Measured within 72 hours following transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 37734031Diamond 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.
- Derived from this study: PubMed 23306540Diamond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
E.J. Demissie, MSN contact
Jason D. Christie, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Graft Dysfunction and Lung Transplantation, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact E.J. Demissie, MSN (215-573-4767), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary graft dysfunction, defined by the ISHLT criteria (time frame: Measured within 72 hours following transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552357, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.