Amotosalen and Platelet Transfusion in Pediatric Heart Surgery

NCT05128084 | Unknown

• 1 other identifier: 7977
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Congenital Heart Disease in Children

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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]

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

Study Officials

• Xavier DELABRANCHE, MD

  Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier DELABRANCHE, MD

CONTACT

33 3 69 55 09 36; xavier.delabranche@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

said.chayer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 19, 2021
• Study Start: October 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 19, 2021

Record last verified: 2021-10

Locations

FR (1)