Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-03 @ 12:59 PM
Study NCT ID:
NCT03156894
Status:
UNKNOWN
Last Update Posted:
2018-01-09
First Post:
2017-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
Heart Transplant and Primary Transplant Dysfunction: a Retrospective Analysis of the Strasbourg Experience
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: