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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT03156894

Collaborator

(none)

100

Enrollment

Location

13.9

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Graft Dysfunction

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Mar 1, 2018

Anticipated Study Completion Date :

Mar 1, 2018

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.