TransAdult: Amotosalen and Platelet Transfusion in Adult Heart Surgery

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05162378

Collaborator

(none)

100

Enrollment

Location

14.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 21, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg	Strasbourg		France	67091

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator: Xavier DELABRANCHE, MD, Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT05162378

Other Study ID Numbers:

7994

First Posted:

Dec 17, 2021

Last Update Posted:

Dec 17, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Strasbourg, France

Study Results

No Results Posted as of Dec 17, 2021