Platelet and Autotransfusion Device in Cardiac Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Anemia less than 7 g/dL
Pregnant women
Redux surgery, dissection, endocarditis, circulatory assistance, and transplants
Contraindication to the use of an autotransfusion device
Trial population
Patients addressed in a university hospital for cardiac surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Autotransfusion device
DeviceStandard cardiac surgery using I-SEP and SAME™ autotransfusion device
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Platelet count
Study the evolution of platelet counts following the use of I-SEP's SAME™ 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 deviceSecondary outcomes
1
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 device2
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 device3
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 device4
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 deviceSponsors and contacts
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Source ClinicalTrials.gov