Amotosalen and Platelet Transfusion in Adult Heart Surgery

NCT05162378 | Unknown

• 1 other identifier: 7994
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Surgery

Keywords

Amotosalen; Platelet transfusion; Bleeding; heart surgery

Outcome Measures

Primary Outcomes (1)

• 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

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major subjects having had cardiac surgery or ascending aorta and platelet transfusion for any reason

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xavier DELABRANCHE, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier DELABRANCHE, MD

CONTACT

33 3 69 55 09 36; xavier.delabranche@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

said.chayer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: December 17, 2021
• Study Start: October 21, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-10

Locations

FR (1)