Lung Transplant; ComplicationsNCT03276403
Primary Graft Dysfunction Score in Lung Transplantation
An observational study of Lung Transplant; Complications, run by Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD at 2 sites in 2 countries.
Trial summary
The validity of several functional parameters, which could be included in a new PGD scoring system, will be tested in a prospective pilot study of 80 consecutive bilateral lung transplant recipients in high volume lung transplant centers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Transplant; Complications
- What is being tested?
- PiCCO Catheter
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2016to 1 Mar 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving double lung transplantation
Who may be able to join
- Double lung transplantation for primary pulmonary hypertension (PPH), Fibrosis, cystic fibrosis (CF), Emphysema
- No restrictions regarding donor lungs (marginal donors, EVLP possible)
- No restrictions regarding size reduction (anatomic wedge resections, three lobar, lobar transplantations)
Who cannot join
- Single-lung transplantation
- Heart-lung transplantation
- Re-transplantation
- Patients with bridge-to-transplantation with a mechanical assist device (extra-corporal membrane oxygenation (v/v, v/a), PA/LA Novalung, ILAactive, ILA)
- Clinical situations leading to inaccurate PiCCO measurements e.g. intracardiac shunts, significant tricuspid regurgitation, cooling
- No access to the femoral artery possible
- Severe postoperative hemorrhage, which leads to hematothorax and makes revision surgery necessary
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Konrad Hoetzenecker, MD,PhD, 0043140400 ext. 56990, konrad.hoetzenecker@meduniwien.ac.at
Thomas Schweiger, MD,PhD, 0043140400 ext. 56990, thomas.schweiger@meduniwien.ac.at
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Shaf Keshavjee, MD, MSc, 001416340 ext. 3863, shaf.keshavjee@uhn.ca
About this study
Official title: Finding New Criteria for a Revised Primary Graft Dysfunction Score in Lung Transplantation - a Pilot Study
The validity of several functional parameters, which could be included in a new PGD scoring system, will be tested in a prospective pilot study of 80 consecutive bilateral lung transplant recipients in high volume lung transplant centers. Functional parameters will be collected at different time points within the first 72hrs after lung transplantation and their accuracy in predicting clinical outcome as well as their correlation with lung water content (measured by PiCCO) will be tested. Insights will serve to generate a hypothesis (a novel PGD score), which can then be tested in future prospective trials.
- Conditions
- Lung Transplant; Complications
- Being tested
- PiCCO Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCCO CatheterDevice
The PiCCO Catheter is an investigational device intended to measure lung water content in individuals requiring advanced haemodynamic monitoring. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary graft dysfunction
Measured: 72 hours after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Nov 2016
- Primary completion1 Dec 2017 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD, Medical University of Vienna
- Investigators
- Konrad Hoetzenecker, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276403
- Sponsor's protocol ID
- 1618/2016
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: IPD will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding New Criteria for a Revised Primary Graft Dysfunction Score in Lung Transplantation - a Pilot Study
- ClinicalTrials.gov ID
- NCT03276403
- Acronym / sponsor ID
- 1618/2016
- Conditions
- Lung Transplant; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assoc.-Prof. Dr. Konrad Hoetzenecker, PhDUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 8 Sep 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.
The validity of several functional parameters, which could be included in a new PGD scoring system, will be tested in a prospective pilot study of 80 consecutive bilateral lung transplant recipients in high volume lung transplant centers. Functional parameters will be collected at different time points within the first 72hrs after lung transplantation and their accuracy in predicting clinical outcome as well as their correlation with lung water content (measured by PiCCO) will be tested. Insights will serve to generate a hypothesis (a novel PGD score), which can then be tested in future prospective trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving double lung transplantation
Key inclusion criteria (3 listed)
- Double lung transplantation for primary pulmonary hypertension (PPH), Fibrosis, cystic fibrosis (CF), Emphysema
- No restrictions regarding donor lungs (marginal donors, EVLP possible)
- No restrictions regarding size reduction (anatomic wedge resections, three lobar, lobar transplantations)
Key exclusion criteria (7 listed)
- Single-lung transplantation
- Heart-lung transplantation
- Re-transplantation
- Patients with bridge-to-transplantation with a mechanical assist device (extra-corporal membrane oxygenation (v/v, v/a), PA/LA Novalung, ILAactive, ILA)
- Clinical situations leading to inaccurate PiCCO measurements e.g. intracardiac shunts, significant tricuspid regurgitation, cooling
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 |
|---|---|---|
| PiCCO CatheterThe PiCCO Catheter is an investigational device intended to measure lung water content in individuals requiring advanced haemodynamic monitoring. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators. | Device | – |
Primary outcome
Primary graft dysfunction
Time frame: 72 hours after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Individual participant dataSharing planned: Undecided. IPD will be shared upon request
Related trials for Lung Transplant; Complications
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
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
Not yet recruiting
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
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.
Konrad Hoetzenecker, MD, PhD principal investigator
Medical University of Vienna
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant; Complications, run by Assoc.-Prof. Dr. Konrad Hoetzenecker, PhD at 2 sites in 2 countries.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konrad Hoetzenecker, MD, PhD (0043140400 ext. 56990, konrad.hoetzenecker@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary graft dysfunction (time frame: 72 hours after transplantation). 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 8 Sep 2017.