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

NCT06425614 | Recruiting DMC

• 2 other identifiers: CHUBX 2022/222022-A02566-39
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

On-pump Cardiac Surgery; High Risk for Bleeding; Autotransfusion

Keywords

cardiac surgery; bleeding; autotransfusion; cardiopulmonary bypass; perioperative haemostasis; Universal Definition of Perioperative Bleeding; filtration-based autotransfusion; centrifugation-based autotransfusion

Outcome Measures

Primary Outcomes (1)

• Perioperative bleeding

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

  At the end of Day 1

Secondary Outcomes (8)

• total blood loss

  Hours 12, Hours 24, up to 5 after operatives days

• surgical re-exploration

  Day 0-Day 5,

• Sternal closure

  Hours 12

• Overall quality of perioperative haemostasis : Use of blood

  Day 0-Day 2,

• Perioperative biological hemostasis

  Pre-inclusion - Day 5

Other Outcomes (17)

• COST-BENEFIT

  Day 30 /+2 days

• Haemoglobin and plasma free haemoglobin

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

• Hematocrit

  During the surgery

Study Arms (2)

Autotransfusion by filtration

EXPERIMENTAL

new filtration-based autotransfusion (SAME I-SEP device)

Procedure: Autotransfusion

Autotransfusion by centrifugation

OTHER

centrifugation-based autotransfusion (routinely used in cardiac surgery centers)

Procedure: Autotransfusion

Interventions

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.

Autotransfusion by centrifugation; Autotransfusion by filtration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (10)

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

Bordeaux, France, 33076, France

RECRUITING

HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation

Bron, 69677, France

NOT YET RECRUITING

CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve

Montpellier, 34295, France

RECRUITING

CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque

Nantes, 44093, France

RECRUITING

Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale

Paris, 75651, France

NOT YET RECRUITING

Hôpital Bichat-Claude Bernard, APHP, Service Anesthésie Réanimation

Paris, 75877, France

NOT YET RECRUITING

Hôpital Européen Georges Pompidou, AP-HP, Service Anesthésie Réanimation

Paris, 75908, France

NOT YET RECRUITING

CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV

Rennes, 35033, France

RECRUITING

CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale

Strasbourg, 67091, France

RECRUITING

CHU Toulouse, Hôpital Rangueil, Service Anesthésie

Toulouse, 31400, France

NOT YET RECRUITING

Related Publications (1)

• Beurton A, Mansour A, Benard A, Pernot M, Brett VE, Batsale C, Aitgougam A, Cordon A, Mouton C, Fresselinat A, Robert G, Imbault J, Nesseler N, Ouattara A. Centrifugation versus filtration-based cell salvage: impact on perioperative bleeding in cardiac surgery-the COLTRANE randomised clinical trial - study protocol. BMJ Open. 2025 Jul 16;15(7):e099423. doi: 10.1136/bmjopen-2025-099423.

  PMID: 40669902 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Blood Transfusion, Autologous

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Alexandre Ouattara, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Ouattara, MD, PhD

CONTACT

0557656866; alexandre.ouattara@chu-bordeaux.fr

Antoine Beurton, MD

CONTACT

0557677147; antoine.beurton@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre clinical trial, Randomized, Comparative, controlled, single blinded, superiority design, two groups.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: May 22, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: June 11, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (10)