Amotosalen and Platelet Transfusion in Pediatric Heart Surgery (TransPédia)

November 18, 2021 updated by: University Hospital, Strasbourg, France

Platelet Transfusion in Pediatric Heart Surgery and Impact of Amotosalen Treatment

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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Minor patient having had cardiac surgery act under cardiopulmonary bypass for correction of congenital heart disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 19, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7977 (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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