An observational study in Congenital Heart Disease in Children, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2021-11-19.
Sponsored by University Hospital, Strasbourg, France · Observational
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).
University Hospital, Strasbourg, France is the lead sponsor of 994 studies on the registry; 353 are open to participants now.
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Minor patient having had cardiac surgery act under cardiopulmonary bypass for correction of congenital heart disease
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Cardiac surgery performed at Bordeaux or Strasbourg University Hospital over two periods:
Exclusion criteria
Retrospective study of the non-inferiority of treatment with Amotosalen of platelet concentrates over transfusion during pediatric cardiac surgery
Time frame: Files analysed retrospectively from January 01, 2016 to June 30, 2019 will be examined]
Started Oct 2020 (actual). Primary completion is estimated for Dec 2021, 14 months after the start.
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This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Strasbourg, France →