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Amotosalen and Platelet Transfusion in Pediatric Heart Surgery

NCT05128084 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2021-11-19

No results posted yet for this study

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

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Xavier DELABRANCHE, MD · Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128084 on ClinicalTrials.gov