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Amotosalen and Platelet Transfusion in Adult Heart Surgery

NCT05162378 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-12-17

No results posted yet for this study

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.

Conditions

  • Heart Surgery

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Xavier DELABRANCHE, MD · Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162378 on ClinicalTrials.gov