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Amotosalen and Platelet Transfusion in Adult Heart Surgery

NCT ID: NCT05162378

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-21

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Surgery

Keywords

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Amotosalen Platelet transfusion Bleeding heart surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier DELABRANCHE, MD

Role: PRINCIPAL_INVESTIGATOR

Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg

Locations

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Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Xavier DELABRANCHE, MD

Role: CONTACT

Phone: 33 3 69 55 09 36

Email: [email protected]

Saïd CHAYER, PhD, HDR

Role: CONTACT

Email: [email protected]

Facility Contacts

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Xavier DELABRANCHE, MD

Role: primary

Saïd CHAYER, PhD, HDR

Role: backup

Other Identifiers

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7994

Identifier Type: -

Identifier Source: org_study_id