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Platelet and Autotransfusion Device in Cardiac Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06629311
Acronym
PLAQ-SES
Enrollment
100
Registered
2024-10-08
Start date
2025-02-04
Completion date
2026-09-08
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autotransfusion Device, Platelets

Keywords

Cardiac surgery, Autotransfusion device, Platelets

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

Interventions

DEVICEAutotransfusion device

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

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Platelet countBefore the use of blood sparing system and 5 minutes after the end of the infusion of blood from the autotransfusion deviceStudy the evolution of platelet counts following the use of I-SEP's SAME™ autotransfusion device in major patients undergoing standard cardiac surgery

Secondary

MeasureTime frame
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
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
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
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

Countries

France

Contacts

Primary ContactCharles TACQUARD, PHU
charlesambroise.tacquard@chru-strasbourg.fr+33 6 69 55 16 08

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026