Amotosalen and Platelet Transfusion in Pediatric Heart Surgery (TransPédia)

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Congenital Heart Disease in Children

Study type: Observational

Funder types: Other

Identifiers

NCT05128084

7977 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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