Amotosalen and Platelet Transfusion in Adult Heart Surgery

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05162378

Acronym

TransAdult

Enrollment

100

Registered

2021-12-17

Start date

2020-10-21

Completion date

2021-12-31

Last updated

2021-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Surgery

Keywords

Amotosalen, Platelet transfusion, Bleeding, heart surgery

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Contacts

Primary ContactXavier DELABRANCHE, MD

xavier.delabranche@chru-strasbourg.fr33 3 69 55 09 36

Backup ContactSaïd CHAYER, PhD, HDR

said.chayer@chru-strasbourg.fr

Outcome results