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

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 Overview

• Status: Unknown
• Conditions: Primary Graft Dysfunction

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service Réanimation chirurgicale cardio-vasculaire - NHC
    • Contact: Alexandre DI MARCO, MD; Phone Number: 33 3 69 55 05 57; Email: alexandre.dimarco@chru-strasbourg.fr
    • Sub-Investigator: Alexandre DI MARCO, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ANTICIPATED): March 1, 2018
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 5, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: heart failure; heart transplant; Primary Graft Dysfunction; Hemodynamic parameters; Graft Dysfunction; Incidence of PDG
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Reperfusion Injury; Primary Graft Dysfunction
• Other Study ID Numbers: 6733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No