Primary Graft DysfunctionNCT02032069
Pneumoproteins Expression in the Organ Donor
An observational study of Primary Graft Dysfunction, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung transplantation, shares key clinical and pathological features with acute lung injury and its more severe form, the acute respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Primary Graft Dysfunction
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Jan 2016
- 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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Organ donors and lung recipients
Who may be able to join
- All the organ donors for lung grafts.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung transplantation, shares key clinical and pathological features with acute lung injury and its more severe form, the acute respiratory distress syndrome. However, in contrast to acute lung injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft dysfunction has been less thoroughly explored. We will try in this study de determine the rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.
- Conditions
- Primary Graft Dysfunction
- Being tested
- no intervention
- Medical subject headings
- Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| NHBD | Non Heart Beating Donors Receives: Other: no intervention | |
| BDD | Brain death donors Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Recipient with primary graft dysfunction
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Graft DysfunctionStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmae Belhaj, University Hospital of Mont-Godinne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032069
- Sponsor's protocol ID
- B406201112693
- Status last verified
- Mar 2016
- First submitted
- 6 Jan 2014
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumoproteins Expression in the Organ Donor
- ClinicalTrials.gov ID
- NCT02032069
- Acronym / sponsor ID
- B406201112693
- Conditions
- Primary Graft Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Jan 2014 (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, a form of reperfusion pulmonary edema that occurs early after lung transplantation, shares key clinical and pathological features with acute lung injury and its more severe form, the acute respiratory distress syndrome. However, in contrast to acute lung injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft dysfunction has been less thoroughly explored. We will try in this study de determine the rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NHBD | – | Other: no interventionNon Heart Beating Donors |
| BDD | – | Other: no interventionBrain death donors |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Organ donors and lung recipients
Key inclusion criteria (1 listed)
- All the organ donors for lung grafts.
Key exclusion criteria (1 listed)
- none
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 intervention | Other | BDD, NHBD |
Primary outcome
Number of Recipient with primary graft dysfunction
Time frame: 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 15 Mar 2016.
Related trials for Primary Graft Dysfunction
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingObservational study
Evaluation of Patients With Immune Function Abnormalities
Chronic Granulomatous Disease (CGD), X-Linked Severe Combined Immune Deficiency (XSCID)
Not yet recruiting
Comparison Between Excision And Primary Anastomosis Urethroplasty And Tunica Vaginalis Graft Urethroplasty.
Urethral Stricture, Erectile Dysfunction
RecruitingObservational study
Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
Primary Graft Dysfunction, Lung Transplantation
Active, not recruitingObservational study
Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation
Primary Graft Dysfunction, Lung Transplantation
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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University Hospital of Mont-Godinne at 1 site in Belgium.
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: finished, as of the sponsor's last update on 15 Mar 2016. 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 Belgium. 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?
Number of Recipient with primary graft dysfunction (time frame: one year). 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 15 Mar 2016.