Amotosalen and Platelet Transfusion in Pediatric Heart Surgery

• Conditions: Congenital Heart Disease in Children

• Registration Number: NCT05128084
• Lead Sponsor: University Hospital, Strasbourg, France

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-11-18
• Last Update Submitted: 2021-11-18
• Study First Posted: 2021-11-19
• Last Update Posted: 2021-11-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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]

Trial Locations

Locations (1)

Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France