Amotosalen and Platelet Transfusion in Pediatric Heart Surgery
NCT ID: NCT05128084
Last Updated: 2021-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2020-10-01
2021-12-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence or installation of transient circulatory assistance (outside of the CEC) or definitive
* Heart or cardiopulmonary transplantation
1 Year
17 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Xavier DELABRANCHE, MD
Role: PRINCIPAL_INVESTIGATOR
Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
Locations
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Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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Xavier DELABRANCHE, MD
Role: primary
Saïd CHAYER, PhD, HDR
Role: backup
Other Identifiers
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7977
Identifier Type: -
Identifier Source: org_study_id