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New treatment option for On-pump Cardiac Surgery
Official title COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial
ClinicalTrials.gov ID: NCT06425614
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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 likely can't join if
- Preoperative therapy by P2Y12 receptor inhibitors (within 5 preoperative days for clopidogrel, ticagrelor or ticlopidine, within 7 preoperative days...
- Preoperative treatment by active anticoagulant drug (within 5 preoperative days for VKA, 4 days for dabigatran, 3 days for rivaroxaban and apixaban...
- Malignant tumor
- Immunocompromised patients (steroids, immunosuppressive drugs, ongoing treatment for solid tumor or hematologic malignancy, primary immunodeficiency...
- Emergency cardiac surgery
- Heart transplantation
See the full eligibility 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
- 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...
- 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 treatment research including a period of exclusion that is still ongoing
- Pregnant or breastfeeding women
- Persons placed under judicial protection
- Patients deprived of liberty
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France, France
- Bron, France
- Montpellier, France
- Nantes, France
- Paris, France
- Rennes, France
- Strasbourg, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France, France; Bron, France; Montpellier, France; Nantes, France; Paris, France; Rennes, France and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.