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NCT05162378 Clinical Trial

Amotosalen and Platelet Transfusion in Adult Heart Surgery

Heart Surgery Clinical Trial

— TransAdult  

Official title:
Impact of Treatment With Amotosalen on the Practice of Platelet Transfusion in Adult Heart Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05162378
Other study ID # 7994
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 21, 2020
Est. completion date December 31, 2021

Study information
Verified date October 2021
Source University Hospital, Strasbourg, France
Contact Xavier DELABRANCHE, MD
Phone 33 3 69 55 09 36
Email xavier.delabranche@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Blood safety is ensured by the rigorous selection of donors and biological tests. However, infectious agents can escape this detection and be transmitted to recipients during transfusion. Amotosalen is a derivative of psoralens that intercalates with nucleic acids and inactivates them after UV exposure; it therefore makes it possible to inhibit any replication of an infectious agent present. Preliminary studies have shown its safety and efficacy in preventing the transmission of infectious agents during the administration of labile blood products (fresh frozen plasma and platelet concentrates) as well as the absence of loss of efficacy (absence of loss of pro-aggregating and procoagulant properties) of the transfused products. In addition, there is a significant reduction in side effects for platelet concentrates, especially compared to irradiated concentrates. Treatment of platelet concentrates with Amotosalen may be responsible for a reduction in the platelet concentration in each concentrate with an overall decrease in efficiency and transfusion yield compared to untreated concentrates.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Major subjects =18 years old - Cardiac surgery or ascending aorta - Platelet transfusion for any reason - Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research Exclusion criteria - Subject having expressed opposition to participating in the study - Presence or - installation of transient circulatory assistance (outside of the CEC) or definitive - Heart or cardiopulmonary transplantation - Subject under guardianship or guardianship - Subject under safeguard of justice

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg 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 study of the impact of the treatment with Amotosalen on the platelet transfusion practice in adult cardiac surgery unit Files analysed retrospectively from January 01, 2016 to June 30, 2019 will be examined
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