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Status unknownNCT03156894Updated Jan 9, 2018

Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience

An observational study in Primary Graft Dysfunction, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Primary Graft Dysfunction

Keywords

  • Graft Dysfunction
  • Primary Graft Dysfunction
  • heart transplant
  • heart failure
  • Hemodynamic parameters
  • Incidence of PDG
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • multi-organ transplants, patients with secondary graft dysfunction and those whose postoperative data were not accessible.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

1 of 1 sites recruiting
  • Service Réanimation chirurgicale cardio-vasculaire - NHC
    Strasbourg, 67091, France
    • Gharib AJOB, MD · Contact · gharib.ajob@chru-strasbourg.fr · 33 3 69 54 97 58
    • Alexandre DI MARCO, MD · Contact · alexandre.dimarco@chru-strasbourg.fr · 33 3 69 55 05 57
    • Gharib AJOB, MD · Principal investigator
    • Alexandre DI MARCO, MD · Sub investigator
    • Paul-Michel MERTES, MD, PhD · Sub investigator
    • Thibaut WIPF, MD · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03156894
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
May 17, 2017
Start date
Jan 1, 2017
Primary completion
Mar 1, 2018 (estimated)
Completion
Mar 1, 2018 (estimated)
Last update
Jan 9, 2018

Study contacts

Gharib AJOB, MD
Contact
gharib.ajob@chru-strasbourg.fr
33 3 69 54 97 58
Alexandre DI MARCO, MD
Contact
alexandre.dimarco@chru-strasbourg.fr
33 3 69 55 05 57

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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