Platelet and Autotransfusion Device in Cardiac Surgery

NCT06629311 — Recruiting, 100 participants, University Hospital, Strasbourg, France
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Study of Platelet Count Changes During the Use of Autotransfusion Device in Cardiac Surgery

RegistryNCT06629311, acronym PLAQ-SES
StatusRecruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorUniversity Hospital, Strasbourg, France (Other)
ConditionsPlatelets, Autotransfusion Device
InterventionsAutotransfusion device (Device)
Datesstart 2025-02-04, primary completion 2026-09-08 (estimated), completion 2026-09-08 (estimated), first posted 2024-10-08, last updated 2025-04-03
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Platelets All trials for Autotransfusion Device All trials of Autotransfusion device

-Summary

Cardiac surgery is a bleeding-risk surgery and frequently requires blood transfusion. Intraoperative autotransfusion devices are used to aspirate, process and retransfuse patients' blood. These devices are effective in recovering red blood cells and limiting the need for transfusion of packed red blood cells. Some devices, such as I-SEP's SAME®, can also be used to recover platelets, but their effectiveness has not yet been evaluated in real-life situations. The aim of this study is therefore to investigate the evolution of platelet counts following the use of an intraoperative recovery device in adult patients undergoing standard cardiac surgery

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+Arms and interventions

  • Autotransfusion device (Device): Standard cardiac surgery using I-SEP and SAME™ autotransfusion device

+Outcome measures

Primary outcomes

  • Platelet count [Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device]: Study the evolution of platelet counts following the use of I-SEP's SAME™ autotransfusion device in major patients undergoing standard cardiac surgery

Secondary outcomes

  • To study the evolution of platelet count following the use of the autotransfusion device (other than SAME) in major patients undergoing standard cardiac surgery. [Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device]
  • To study the evolution of platelet function (flow cytometry and flow aggregation) following the use of a autotransfusion device in major patients undergoing standard cardiac surgery. [Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device]
  • Study the evolution of platelet function according to the autotransfusion device used. [Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device]
  • Study post-operative bleeding volume as a function of autotransfusion device type. [Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device]
  • Study the volume of labile blood product transfusion according to the autotransfusion device used. [Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device]
  • Study the intensity of post-operative inflammatory syndrome as a function of the autotransfusion device used. [Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device]
  • Study platelet adhesion to the autotransfusion device membranes using electron microscopy. [Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients over 18 years of age
* Having undergone standard cardiac surgery (excluding redux surgery, dissection, endocarditis, circulatory assist and transplants)
* Treated with an autotransfusion device during the surgery
* Subject having expressed their consent to the study

Exclusion Criteria:

* Anemia less than 7 g/dL
* Pregnant women
* Redux surgery, dissection, endocarditis, circulatory assistance, and transplants
* Contraindication to the use of an autotransfusion device
* Impossibility of giving the subject informed information

+Locations (1)

FacilityCityCountryStatus
Hôpitaux Universitaires de StrasbourgStrasbourg, Bas-RhinFranceRecruiting