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

NCT ID: NCT03156894

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Graft Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service Réanimation chirurgicale cardio-vasculaire - NHC

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gharib AJOB, MD

Role: CONTACT

33 3 69 54 97 58

Alexandre DI MARCO, MD

Role: CONTACT

33 3 69 55 05 57

Facility Contacts

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Gharib AJOB, MD

Role: primary

33 3 69 54 97 58

Alexandre DI MARCO, MD

Role: backup

33 3 69 55 05 57

Other Identifiers

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6733

Identifier Type: -

Identifier Source: org_study_id

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