Using a new device to recover blood components during cardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The COLTRANE trial investigates the use of a novel filtration-based autotransfusion device, known as SAME, during on-pump cardiac surgeries that are at high risk for bleeding. This device aims to recover not only red blood cells but also platelets and leukocytes from shed blood, potentially improving perioperative haemostasis. By re-infusing patients with their own platelets, the study seeks to reduce the need for blood product transfusions and minimize postoperative complications. The trial will assess the safety and feasibility of this approach in a multicenter setting involving several hospitals in France.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire
  Bordeaux, France, France Recruiting
• CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve
  Montpellier, France Recruiting
• CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque
  Nantes, France Recruiting
• CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV
  Rennes, France Recruiting
• CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale
  Strasbourg, France Recruiting
• HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation
  Bron, France Not yet recruiting

Study contacts

• Principal investigator: Alexandre Ouattara, MD, PhD — University Hospital, Bordeaux
• Study coordinator: Alexandre Ouattara, MD, PhD
• Email: alexandre.ouattara@chu-bordeaux.fr
• Phone: 0557656866

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.