Amotosalen and Platelet Transfusion in Adult Heart Surgery (TransAdult)

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Heart Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05162378

7994

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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