Clinical trial NCT06629311: Platelet and Autotransfusion Device in Cardiac Surgery
Official title: Study of Platelet Count Changes During the Use of Autotransfusion Device in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Platelets
Autotransfusion Device
Keywords: Cardiac surgery
Autotransfusion device
Platelets
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients addressed in a university hospital for cardiac surgery

Brief 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


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

Primary outcomes:
measure: Platelet count
timeFrame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Secondary outcomes:
measure: To study the evolution of platelet count following the use of the autotransfusion device (other than SAME) in major patients undergoing standard cardiac surgery.
timeFrame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
measure: 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.
timeFrame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
measure: Study the evolution of platelet function according to the autotransfusion device used.
timeFrame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
measure: Study post-operative bleeding volume as a function of autotransfusion device type.
timeFrame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
measure: Study the volume of labile blood product transfusion according to the autotransfusion device used.
timeFrame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
measure: Study the intensity of post-operative inflammatory syndrome as a function of the autotransfusion device used.
timeFrame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
measure: Study platelet adhesion to the autotransfusion device membranes using electron microscopy.
timeFrame: Before the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion device
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
state: Bas-Rhin
Study officials:
References: