Amotosalen and Platelet Transfusion in Pediatric Heart Surgery

Platelet Transfusion in Pediatric Heart Surgery and Impact of Amotosalen Treatment

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05128084

Acronym

TransPédia

Enrollment

Registered

2021-11-19

Start date

2020-10-01

Completion date

2021-12-31

Last updated

2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease in Children

Keywords

Congenital Heart, Platelet transfusion, Procoagulant drugs, Amotosalen, Pediatric heart surgery

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame
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]

Countries

France

Contacts

Primary ContactXavier DELABRANCHE, MD

xavier.delabranche@chru-strasbourg.fr33 3 69 55 09 36

Backup ContactSaïd CHAYER, PhD, HDR

said.chayer@chru-strasbourg.fr

Outcome results