Amotosalen and Platelet Transfusion in Pediatric Heart Surgery

Congenital Heart Disease in Children Clinical Trial

— TransPédia  

Official title:

Platelet Transfusion in Pediatric Heart Surgery and Impact of Amotosalen Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05128084
• Other study ID #: 7977
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: Xavier DELABRANCHE, MD
• Phone: 33 3 69 55 09 36
• Email: xavier.delabranche[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
France	Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]