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Recruiting NCT06629311

Platelet and Autotransfusion Device in Cardiac Surgery

— Observational Platelets Autotransfusion Device

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autotransfusion device.
Who it may be relevant to
Registry conditions: Platelets, Autotransfusion Device. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Study of Platelet Count Changes During the Use of Autotransfusion Device in Cardiac Surgery

Overview

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

Interventions

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

Primary outcome measures

  • Platelet count [Time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device]
Secondary outcome measures (7)
  • To study the evolution of platelet count following the use of the autotransfusion device (other than SAME) in major patients undergoing standard cardiac surgery. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpitaux Universitaires de Strasbourg — Strasbourg

Identifiers

NCT: NCT06629311 · 9264

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗