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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03156894

Enrollment

100

Registered

2017-05-17

Start date

2017-01-01

Completion date

2018-03-01

Last updated

2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Graft Dysfunction

Keywords

Graft Dysfunction, Primary Graft Dysfunction, heart transplant, heart failure, Hemodynamic parameters, Incidence of PDG

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame
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	1 month after leaving the operating room

Countries

France

Contacts

Primary ContactGharib AJOB, MD

gharib.ajob@chru-strasbourg.fr33 3 69 54 97 58

Backup ContactAlexandre DI MARCO, MD

alexandre.dimarco@chru-strasbourg.fr33 3 69 55 05 57

Outcome results