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NCT Number: NCT06629311

Platelet and Autotransfusion Device in Cardiac Surgery

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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Key information

Conditions

Platelets Autotransfusion Device

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, Bas-Rhin, 67091, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autotransfusion device

Device

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

Primary outcomes

  1. 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

    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

  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 device

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Charles TACQUARD, PHU

CONTACT

[email protected]

+33 6 69 55 16 08

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: PLAQ-SES

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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