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

NCT03156894 | Unknown

• 1 other identifier: 6733
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Graft Dysfunction

Keywords

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

Outcome Measures

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

  1 month after leaving the operating room

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service Réanimation chirurgicale cardio-vasculaire - NHC

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Primary Graft Dysfunction; Heart Failure

Condition Hierarchy (Ancestors)

Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases

Central Study Contacts

Gharib AJOB, MD

CONTACT

33 3 69 54 97 58; gharib.ajob@chru-strasbourg.fr

Alexandre DI MARCO, MD

CONTACT

33 3 69 55 05 57; alexandre.dimarco@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: May 17, 2017
• Study Start: January 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: January 9, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)