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NCT Number: NCT06425614

COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial

Despite significant advances in patient blood management, cardiac surgery remains a surgical procedure at high risk for bleeding. Numerous perioperative blood conservation strategies have been developed for limiting the use of blood products. Among them, the processing of shed blood and residual cardiopulmonary bypass circuit volume with autotransfusion device is routinely used. Conventional centrifugation-based autotransfusion devices actually available only recover red blood cells while platelets and coagulation factors are almost totally lost. Consequently, large amounts of intraoperative cell salvage could significantly alter perioperative haemostasis. The SAME autotransfusion device (i-SEP, France) is a new and innovative filtration-based autotransfusion device able to recover erythrocytes, leukocytes but also platelets. By offering the opportunity to re-infuse to patients their own platelets in addition red blood cells, significantly improve perioperative haemostasis with this new device is expected. The purpose of the COLTRANE trial is to compare the quality of the perioperative haemostasis in cardiac surgical patients for whom intraoperative cell salvage will be performed using either the SAME autotransfusion device or conventional centrifugation-based device.

Because allogenic transfusion of blood products as well as surgical re-exploration for excessive bleeding are associated with poor outcomes and prolonged length of stay, the use of filtration-based SAME device by maintaining perioperative haemostasis could improve outcomes and reduce length of stay of high risk patients. The fact that patients receive their own platelets should also limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection.

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Key information

Conditions

On-pump Cardiac Surgery Autotransfusion Hemorrhage High Risk for Bleeding Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire, Bordeaux, France

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About this study

The SAME device is a new and innovative filtration-based autotransfusion device able to recover both erythrocytes and platelets. A multicentre single-arm clinical feasibility and safety trial conducted by our group, using SAME device on 50 cardiac surgical patients reported erythrocyte yield per cycle of 89%, post-treatment hematocrit of 43% with an excellent washing performance. In addition, the device recovered 52% of platelets, that were found unaltered by the device as demonstrated by a limited platelet activation and a strong response to thrombin-pathway stimulation assessed by flow cytometry. By offering the opportunity to re-infuse to the patients their own platelets in addition to their RBC, this new device might significantly improve perioperative haemostasis and thus decrease the need for blood products. It is well established that severe postoperative bleeding and blood products transfusion lead to increase morbidity and mortality. Consequently, an improvement of postoperative outcomes and a decrease in intensive care unit (ICU) and hospital length of stay may be expected. The fact that patients receive their own platelets should limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection. Consequently, a reduction of infectious complication may be also expected.

The purpose of COLTRANE trial is to test the hypothesis that the intraoperative use of the filtration-based SAME autotransfusion device could improve perioperative haemostasis thereby reducing the proportion of patients exhibiting clinically significant perioperative bleeding (moderate to massive bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adult patients (≥18 yr) affiliated or beneficiary of a social security scheme and undergoing on-pump cardiac surgery at high risk for bleeding with autotranfusion indication defined as:

  • Primary or redo combined cardiac procedures (2 valves or more, valve(s) and coronary artery bypass grafting(s))
  • Primary or redo ascending aorta surgery
  • Primary or redo isolated coronary artery bypass grafting (iCABG) involving 3 or more grafts using the internal mammary artery
  • Free, informed and written consent signed by the participant and the investigator

Exclusion criteria

  • Preoperative therapy by P2Y12 receptor inhibitors (within 5 preoperative days for clopidogrel, ticagrelor or ticlopidine, within 7 preoperative days for prasugrel, and within one preoperative hour for cangrelor)
  • Preoperative treatment by active anticoagulant drug (within 5 preoperative days for VKA, 4 days for dabigatran, 3 days for rivaroxaban and apixaban, 24 hours for therapeutic LMWH, 36 hours for therapeutic fondaparinux, 12 hours for prophylactic LMWH, 24 hours for prophylactic fondaparinux, 4 hours for unfractionated heparin Sepsis
  • Malignant tumor
  • Immunocompromised patients (steroids, immunosuppressive drugs, ongoing treatment for solid tumor or hematologic malignancy, primary immunodeficiency disorders, AIDS)
  • Emergency cardiac surgery
  • Heart transplantation
  • Implantation or patients under ventricular assist device (VAD)
  • Patients with two or more previous sternotomy
  • Surgery procedure requiring circulatory arrest and/or profound hypothermia (<32°C)
  • Active infective endocarditis
  • Cardiac surgical procedure for benign or malignant cardiac tumors
  • Patients with known acquired or constitutional coagulopathy requiring specialist management
  • End stage renal disease
  • Preoperative haemoglobin level less than 10 g/dL
  • Preoperative platelet count < 100 G/L
  • Persons participating in another interventional research including a period of exclusion that is still ongoing
  • Pregnant or breastfeeding women
  • Persons placed under judicial protection
  • Patients deprived of liberty

Treatment and study plan

Autotransfusion

Procedure

ANTIFIBRINOLYTIC THERAPY :

tranexamic acid as antifibrinolytic therapy : dose after anaesthesia induction followed by continuous intravenous infusion until end

INTRAOPERATIVE MANAGEMENT :

  • Routine monitoring : five lead-ECG, pulse oximeter, non-invasive arterial pressure will be instituted. A peripheral venous catheter and an arterial catheter
  • The general anaesthesia :
  • propofol and Remifentanil or sufentanil both simultaneously administered .
  • monitoring of the bispectral index
  • Triple lumen central venous catheter
  • Heparinization (300 UI/kg)
  • Aortic and right auricular cannulations

TRANSFUSION PROTOCOL :

  • During CPB, PRBC transfusion if necessary
  • In the postoperative period if necessary

In bleeding patients:

The perioperative use of blood products will be managed according to results of conventional haemostasis tests or viscoelastic point of care tests when available in the center.

Primary outcomes

  1. Perioperative bleeding

    Time frame: At the end of Day 1

    The proportion of patients with clinically significant (moderate to massive) perioperative bleeding according to the Universal Definition for Perioperative Bleeding.

Secondary outcomes

  1. total blood loss

    Time frame: Hours 12, Hours 24, up to 5 after operatives days

    Total blood loss from chest tubes within 12 and 24 postoperative hours and up to chest tubes removal (maximum 5 postoperative days)

  2. surgical re-exploration

    Time frame: Day 0-Day 5,

    Surgical re-exploration for excessive bleeding within 5 postoperative days

  3. Sternal closure

    Time frame: Hours 12

    Delayed sternal closure

  4. Overall quality of perioperative haemostasis : Use of blood

    Time frame: Day 0-Day 2,

    Perioperative use of blood products and/or plasma derivatives within 2 postoperative days including PRBC, PLT, FFP, fibrinogen concentrate, PCCs, rFVIIa

  5. Perioperative biological hemostasis

    Time frame: Pre-inclusion - Day 5

    Coagulation tests (PT, aPTT, fibrinogen level) preoperatively, at the end of the surgery (+ thrombin time or ACT ), at arrival in ICU and at POD1, 3 and 5

  6. Complete blood count

    Time frame: Pre-inclusion - Day 5

    Complete blood count preoperatively, at the end of the surgery, at arrival in ICU and at POD1, 3 and 5.

  7. ICU and hospital length of stay

    Time frame: End of study or early termination- Day 30

    calculated ICU and hospital free days

  8. Early postoperative morbidity within 30 postoperative days

    Time frame: Day 30

    Cardiovascular: need for inotropes and/or vasopressors intravenous infusion >24 hours, need for short-term mechanical circulatory support, occurrence of atrial fibrillation and/or ventricular fibrillation/tachycardia, high grade atrioventricular bloc, myocardial infarction, tamponade, symptomatic thromboembolic events.

    Respiratory: duration of mechanical ventilation, re-intubation, ARDS according the Berlin criteria, need for VV ECMO Renal: Kidney Disease Improving Global Outcomes stage (KDIGO) ≥2; need for renal replacement therapy. Serum electrolytes and renal function preoperatively, at arrival in ICU and at POD1, 3 and 5.

    Neurology: transient and permanent stroke, epilepsy, confusion Infectious: mediastinitis, septic shock, pneumopathy and bacteremia Abdominal: mesenteric ischemia, upper and/or lower gastrointestinal bleeding. Liver function tests preoperatively, at arrival in ICU and at POD1, 3 and 5.

    30-day all-cause mortality

Other outcomes

  1. COST-BENEFIT

    Time frame: Day 30 /+2 days

    • Hospital incomes will correspond to the Groupe Homogène de Séjour (GHS) of each patient
    • Hospital expenditure (in-hospital stay, operating room occupancy, transfusions, treatment of infections) valued in the perspective of hospital centers, using data from the national cost studies with common methodology and from analytical accounting.
    • The difference between hospital incomes and hospital expenditures for each patient will be used to estimate the cost-benefit of the filtration-based autotransfusion SAME device as compared to centrifugation-based autotransfusion devices.

  2. Haemoglobin and plasma free haemoglobin

    Time frame: just before surgery as well as 6+/-2 hours after surgery

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles.

    • Laboratory analyses: haemoglobin level and plasma free haemoglobin will be performed Blood samples will be also collected from the patient just before surgery as well as 6+/-2 hours after surgery to measure plasma free haemoglobin level.

  3. Hematocrit

    Time frame: During the surgery

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles.

    • Laboratory analyses: hematocrit level will be performed.

  4. Complete blood count

    Time frame: During the surgery

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles.

    • Laboratory analyses: complete blood count will be performed

  5. Unfractionated heparin anti-Xa

    Time frame: During the surgery

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles.

    • Laboratory analyses: unfractionated heparin anti-Xa level will be performed

  6. Fibrinogen

    Time frame: During the surgery

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles.

    • Laboratory analyses: fibrinogen level will be performed

  7. Triglycerides

    Time frame: During the surgery

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles.

    • Laboratory analyses: triglycerides level will be performed

  8. Total proteins

    Time frame: During the surgery

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles.

    • Laboratory analyses: total proteins level will be performed

  9. Potassium

    Time frame: During the surgery

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post treatment) during the first two processing cycles.

    • Laboratory analyses: potassium level will be performed

  10. Blood viscoelasticity assessment

    Time frame: just before and immediately after re-infusion, pré-treatment and just after traitement by the autotransfusion device

    Patients in whom the salvaged blood from mediastinal shed and residual cardiopulmonary bypass circuit volume will be processed and not reinfused before protamine infusion will be included in this ancillary study.

    Blood samples will be collected from the patient just before and immediately after re-infusion of the processed blood and sent to the haematology laboratory to perform viscoelasticity assessment Quantra QPlus™

  11. Complete bloof count

    Time frame: just before and immediately after re-infusion, pré-treatment and just after traitement by the autotransfusion device

    Patients in whom the salvaged blood from mediastinal shed and residual cardiopulmonary bypass circuit volume will be processed and not reinfused before protamine infusion will be included in this ancillary study.

    Blood samples will be collected from the patient just before and immediately after re-infusion of the processed blood and sent to the haematology laboratory to complete blood count.

  12. INF-γ profiling by mass cytometry CyTOF

    Time frame: just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF).

    Blood samples will be also collected from the patient for INF-γ assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery

  13. IL-1β-γ profiling by mass cytometry CyTOF

    Time frame: just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF).

    Blood samples will be also collected from the patient for IL-1β assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery

  14. Il-6 profiling by mass cytometry CyTOF

    Time frame: just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF).

    Blood samples will be also collected from the patient for Il-6 assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery

  15. IL-8 profiling by mass cytometry CyTOF

    Time frame: just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF).

    Blood samples will be also collected from the patient for IL-8 assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery

  16. IL-10 profiling by mass cytometry CyTOF

    Time frame: just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF).

    Blood samples will be also collected from the patient for IL-10 assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery

  17. TNFα profiling by mass cytometry CyTOF

    Time frame: just before surgery, one day after surgery, pré-treatment and just after treatment by the autotransfusion device

    Blood samples will be collected from the collection reservoir (pre-treatment) of the autotransfusion device and from the reinfusion bag (post-treatment) during the first cycle of processing for immunology assessment (immune profiling by mass cytometry CyTOF).

    Blood samples will be also collected from the patient for TNFα assessment (by mass cytometry CyTOF) immediately just before surgery as well as one day after surgery

Study contacts

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

Alexandre Ouattara, MD, PhD

CONTACT

[email protected]

0557656866 ext. +33

Antoine Beurton, MD

CONTACT

[email protected]

0557677147

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Centrifugation-based Versus Filtration-based Intraoperative Cell Salvage on Quality of Perioperative Haemostasis in Cardiac Surgery: A Randomized Clinical Trial

Acronym: COLTRANE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 22, 2024
Registry last updated
Jun 11, 2026

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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