Lung Transplant FailureNCT03052153
Intraoperative Echocardiographic Evaluation of Pulmonary Vein Velocities and Outcomes in Lung Transplantation
An observational study of Lung Transplant Failure, run by Ohio State University at 1 site in United States.
Trial summary
This study will evaluate if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant Failure
- What is being tested?
- No investigational intervention performed for this study
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2017to 4 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include all surgical patients 18 years of age and older who underwent single or bilateral lung transplantation surgery during the period January 1st 2014 to November 18 2016 at Ohio State University Wexner Medical Center. Database screening for patient inclusion in retrospective analysis will be performed by designated personnel from the Anesthesiology Department or co-investigators entitled to work with patients' electronic data.
Who may be able to join
- All adult patients ≥ 18 years of age
- Having undergone single or bilateral lung transplantation surgery at Ohio State University Wexner Medical Center between January 1st 2014 and November 18th 2016
Who cannot join
- 1. Patients ≤ 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
This study will evaluate if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively.
Read the detailed description
Lung transplantation surgery can be fraught with a multitude of early as well as delayed complications leading to increased morbidity and mortality. During lung transplant surgery, trans-esophageal echocardiography (TEE) is routinely used to identify cardiac anatomy and measure blood flow through the pulmonary veins. This blood flow is assessed both before and after the lung has been transplanted. Blood flow through these small caliber vessels can be impacted by many variables with a resulting reduction in blood circulating to the lung, although currently there is no agreement on an acceptable level of flow. This study will look at retrospective data from lung transplant surgeries undertaken at this institution since Jan 1st 2014 until November 18th 2016 with the goal of determining if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively.
- Conditions
- Lung Transplant Failure
- Being tested
- No investigational intervention performed for this study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No investigational intervention performed for this studyOther
No investigational intervention for the purpose of this study was performed; data collected is retrospective data previously collected for non-research purposes.
| Study group | Role | What they receive |
|---|---|---|
| Lung Transplant Surgery | Subjects included in the study will have undergone a single or bilateral lung transplant surgery at The Ohio State University Wexner Medical Center between 01 JAN 2014 and 18 NOV 2016. No investigational intervention performed for this study. Receives: Other: No investigational intervention performed for this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of graft dysfunction
To describe the relationship between intra-operative pulmonary vein systolic velocities and the incidence of graft dysfunction as defined by the International Society for Heart and Lung Transplantation (ISHLT).
Measured: at 30 days post-transplant
grade of graft dysfunction
To describe the relationship between intra-operative pulmonary vein systolic velocities and grade of graft dysfunction as defined by the International Society for Heart and Lung Transplantation (ISHLT).
Measured: at 30 days post-transplant
Secondary outcomes (2)
All-cause mortality
To measure and report all-cause mortality at 30 days post-transplant.
Measured: at 30 days post-transplant
Hospital Length of Stay
To report subjects hospital length of stay for up to one year.
Measured: From hospital admission to discharge up to one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start17 Mar 2017
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant FailureStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amar Bhatt, Ohio State University
- Investigators
- Amar Bhatt, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052153
- Sponsor's protocol ID
- 2016H0435
- Status last verified
- Sep 2021
- First submitted
- 7 Jan 2017
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Echocardiographic Evaluation of Pulmonary Vein Velocities and Outcomes in Lung Transplantation
- ClinicalTrials.gov ID
- NCT03052153
- Acronym / sponsor ID
- 2016H0435
- Conditions
- Lung Transplant Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 14 Feb 2017 (actual)
- 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.
This study will evaluate if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively.
Detailed description
Lung transplantation surgery can be fraught with a multitude of early as well as delayed complications leading to increased morbidity and mortality. During lung transplant surgery, trans-esophageal echocardiography (TEE) is routinely used to identify cardiac anatomy and measure blood flow through the pulmonary veins. This blood flow is assessed both before and after the lung has been transplanted. Blood flow through these small caliber vessels can be impacted by many variables with a resulting reduction in blood circulating to the lung, although currently there is no agreement on an acceptable level of flow. This study will look at retrospective data from lung transplant surgeries undertaken at this institution since Jan 1st 2014 until November 18th 2016 with the goal of determining if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Transplant Surgery | – | Other: No investigational intervention performed for this studySubjects included in the study will have undergone a single or bilateral lung transplant surgery at The Ohio State University Wexner Medical Center between 01 JAN 2014 and 18 NOV 2016. No investigational intervention performed for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all surgical patients 18 years of age and older who underwent single or bilateral lung transplantation surgery during the period January 1st 2014 to November 18 2016 at Ohio State University Wexner Medical Center. Database screening for patient inclusion in retrospective analysis will be performed by designated personnel from the Anesthesiology Department or co-investigators entitled to work with patients' electronic data.
Key inclusion criteria (2 listed)
- All adult patients ≥ 18 years of age
- Having undergone single or bilateral lung transplantation surgery at Ohio State University Wexner Medical Center between January 1st 2014 and November 18th 2016
Key exclusion criteria (1 listed)
- 1. Patients ≤ 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No investigational intervention performed for this studyNo investigational intervention for the purpose of this study was performed; data collected is retrospective data previously collected for non-research purposes. | Other | Lung Transplant Surgery |
Primary outcome
incidence of graft dysfunction
Time frame: at 30 days post-transplant
To describe the relationship between intra-operative pulmonary vein systolic velocities and the incidence of graft dysfunction as defined by the International Society for Heart and Lung Transplantation (ISHLT).
grade of graft dysfunction
Time frame: at 30 days post-transplant
To describe the relationship between intra-operative pulmonary vein systolic velocities and grade of graft dysfunction as defined by the International Society for Heart and Lung Transplantation (ISHLT).
2 secondary outcomes
All-cause mortality
Time frame: at 30 days post-transplant
Hospital Length of Stay
Time frame: From hospital admission to discharge up to one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Lung Transplant Failure
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Enrolling by invitationPhase 2
Chronic Exogenous Ketosis in HFpEF
Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Normal Ejection Fraction
Not yet recruiting
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
Congenital Heart Disease, Advanced Heart Failure
Active, not recruitingObservational study
Bio-Banking of Specimens for Advanced Lung Disease and Lung Transplant Research
Respiratory Failure, Interstitial Lung Disease
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. This study is not recruiting at the moment.
Amar Bhatt, MD principal investigator
Ohio State University
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 Lung Transplant Failure, run by Ohio State University 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 2 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: finished, as of the sponsor's last update on 9 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of graft dysfunction (time frame: at 30 days post-transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2021.