Primary Graft DysfunctionNCT03156894
Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience
An observational study of Primary Graft Dysfunction, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Among the complications of heart transplant, primary dysfunction of the graft (PDG) is the most feared with a net impact on early morbidity and mortality. The all-cause mortality rate at the international level is 10% at 30 days and 34% at one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Graft Dysfunction
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2017to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who had an isolated heart transplant in the cardiac surgery department of HUS (Hôpitaux Univertsitaires de Strasbourg) between June 2008 and December 2015.
Who may be able to join
- All patients who had an isolated heart transplant in the cardiac surgery department of HUS (Hôpitaux Univertsitaires de Strasbourg) between June 2008 and December 2015.
Who cannot join
- multi-organ transplants, patients with secondary graft dysfunction and those whose postoperative data were not accessible.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Réanimation chirurgicale cardio-vasculaire - NHC
Strasbourg, 67091
Gharib AJOB, MD, 33 3 69 54 97 58, gharib.ajob@chru-strasbourg.fr
Alexandre DI MARCO, MD, 33 3 69 55 05 57, alexandre.dimarco@chru-strasbourg.fr
About this study
Among the complications of heart transplant, primary dysfunction of the graft (PDG) is the most feared with a net impact on early morbidity and mortality. The all-cause mortality rate at the international level is 10% at 30 days and 34% at one year. Mortality at 30 days is secondary in 66% of cases with DPG or multi-organ failure.
The treatment of choice for the more severe PDG remains ECMO-type circulatory mechanical assistance or ventricular assistance. According to several studies, this could reduce early mortality. Early placement and short-term (<30 days) of support appear to improve survival in the first year after transplantation.
Read more
The haemodynamic parameters revealing this DPG are not clearly described in the literature.
hypothesis of this research is that:
- DPG risk factors in strasbourg's hospital center are comparable to other European and international centers.
- Simple hemodynamic parameters can be used to detect PDG earlier in order to set up assistance more quickly.
- Conditions
- Primary Graft Dysfunction
- Keywords
- Graft Dysfunction, Primary Graft Dysfunction, heart transplant, heart failure, Hemodynamic parameters, Incidence of PDG
- Medical subject headings
- Primary Graft Dysfunction, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective comparison of risk factors (incidence for ordinal and average variables for numerical variables) between patients suffering from severe primary dysfunction of the graft and those not suffering from severe primary dysfunction of the graft
Measured: 1 month after leaving the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Jan 2017
- Primary completion1 Mar 2018 (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 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156894
- Sponsor's protocol ID
- 6733
- Status last verified
- May 2017
- First submitted
- 4 Jan 2017
- Last updated
- 9 Jan 2018
- 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 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience
- ClinicalTrials.gov ID
- NCT03156894
- Acronym / sponsor ID
- 6733
- Conditions
- Primary Graft Dysfunction
- Keywords
- Graft Dysfunction, Primary Graft Dysfunction, heart transplant, heart failure, Hemodynamic parameters, Incidence of PDG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 17 May 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.
Among the complications of heart transplant, primary dysfunction of the graft (PDG) is the most feared with a net impact on early morbidity and mortality. The all-cause mortality rate at the international level is 10% at 30 days and 34% at one year. Mortality at 30 days is secondary in 66% of cases with DPG or multi-organ failure.
The treatment of choice for the more severe PDG remains ECMO-type circulatory mechanical assistance or ventricular assistance. According to several studies, this could reduce early mortality. Early placement and short-term (<30 days) of support appear to improve survival in the first year after transplantation.
The haemodynamic parameters revealing this DPG are not clearly described in the literature.
hypothesis of this research is that:
- DPG risk factors in strasbourg's hospital center are comparable to other European and international centers.
- Simple hemodynamic parameters can be used to detect PDG earlier in order to set up assistance more quickly.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had an isolated heart transplant in the cardiac surgery department of HUS (Hôpitaux Univertsitaires de Strasbourg) between June 2008 and December 2015.
Key inclusion criteria (1 listed)
- All patients who had an isolated heart transplant in the cardiac surgery department of HUS (Hôpitaux Univertsitaires de Strasbourg) between June 2008 and December 2015.
Key exclusion criteria (1 listed)
- multi-organ transplants, patients with secondary graft dysfunction and those whose postoperative data were not accessible.
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
Retrospective comparison of risk factors (incidence for ordinal and average variables for numerical variables) between patients suffering from severe primary dysfunction of the graft and those not suffering from severe primary dysfunction of the graft
Time frame: 1 month after leaving the operating room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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, Strasbourg, France at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 9 Jan 2018. 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 France. 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 Gharib AJOB, MD (33 3 69 54 97 58, gharib.ajob@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective comparison of risk factors (incidence for ordinal and average variables for numerical variables) between patients suffering from severe primary dysfunction of the graft and those not suffering from severe primary dysfunction of the graft (time frame: 1 month after leaving the operating room). 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 Jan 2018.