TransPédia: Amotosalen and Platelet Transfusion in Pediatric Heart Surgery

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05128084
Collaborator
(none)
50
Enrollment
1
Location
15
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

High level of security during blood transfusion has been achieved by donor selection and pathogen detection using serology or direct identification. Nevertheless, blood banking becomes hazardous during epidemic outbreaks or facing new pathogens. Amotosalen, a psoralen, targets nucleic acids and destroys them after ultraviolet exposure, resulting in inactivation of pathogens.

Treatment inoccuity and efficacy have been demonstrated but preservation of platelet functions after treatment is still debated. Previous studies focused on hematological patients. There is no evidence for an increased requirement of transfused platelets to achieve platelet count target. Studies in heart surgery are lacking.

The investigators perform a multicenter, retrospective, "before/after", controlled study in minor patients requiring heart surgery with cardiopulmonary bypass. One center (Strasbourg) uses Amotosalen-treated platelet concentrates since 2006 (control arm). This treatment becomes available in Bordeaux in October 2017 (intervention arm). There is two periods of inclusion: one "before" (January 2016 to June 2017) and one "after" (January 2018 to June 2019).

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Platelet Transfusion in Pediatric Heart Surgery and Impact of Amotosalen Treatment
    Actual Study Start Date :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Retrospective study of the non-inferiority of treatment with Amotosalen of platelet concentrates over transfusion during pediatric cardiac surgery [Files analysed retrospectively from January 01, 2016 to June 30, 2019 will be examined]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    Inclusion criteria:
    • Minor patient (<18 years old)

    • Cardiac surgery act under cardiopulmonary bypass for correction of congenital heart disease

    • Platelet transfusion for any reason

    • Cardiac surgery performed at Bordeaux or Strasbourg University Hospital over two periods:

    • Period A: January 01, 2016 - June 30, 2017 (before treatment)

    • Period B: January 01, 2018 - June 30, 2019 (after treatment)

    • Subject (and / or his parental authority) not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

    Exclusion criteria

    • Subject (and / or his parental authority) having expressed, after information, his opposition to the reuse of his data for the purposes of this research

    • Presence or installation of transient circulatory assistance (outside of the CEC) or definitive

    • Heart or cardiopulmonary transplantation

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de StrasbourgStrasbourgFrance67091

    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:
    NCT05128084
    Other Study ID Numbers:
    • 7977
    First Posted:
    Nov 19, 2021
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 19, 2021