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

Primary Graft Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03156894
• Other study ID #: 6733
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2017
• Last updated: January 5, 2018
• Start date: January 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: May 2017
• Source: University Hospital, Strasbourg, France
• Contact: Gharib AJOB, MD
• Phone: 33 3 69 54 97 58
• Email: gharib.ajob[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Graft Dysfunction

Locations

Country	Name	City	State
France	Service Réanimation chirurgicale cardio-vasculaire - NHC	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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