CHU de Rouen
Rouen, France
NCT Number: NCT07822620
Cardiac surgery is at high risk of intraoperative bleeding. Inhibitors of the P2Y12 platelet receptor, such as ticagrelor, are recommended in patients with acute coronary stroke (ACS) to reduce the incidence of major cardiovascular events. Nevertheless, some patients may require coronary artery bypass graft under cardiac bypass after ticagrelor administration. This administration within 48 hours prior to surgery is associated with a significant increase in bleeding and related poor outcomes, notably because platelet transfusion fails to reverse ticagrelor induced platelet dysfunction. Conversely, waiting several days to plan surgery, in the idea of clearing blood from ticagrelor, exposes to a risk of ischemic recurrence.
Another situation where ticagrelor administration may impend prognosis is emergent aortic surgeries, including aortic dissection or aneurysm rupture. Ticagrelor is frequently administrated because symptoms can mimic ACS, but it may increase bleeding and transfusion by at least 50%.
Several case reports and cohorts described blood hemadsorption, using the Cytosorb® blood purification system (Cytosorb®ents, USA) as a reversal therapy for ticagrelor, reducing bleeding. Cytosorb® is a polymeric beads system with a large exchange surface, enabling the adsorption and removal of molecules of intermediate sizes (< 60 kDa). It has been described to reduce the plasma levels of ticagrelor, with a removal up to 75% after 60 min. It can be connected directly to the heart-lung machine. Its use during cardiac bypass is simple and has not described to induce additional hemolysis.
We hypothesize that the use of Cytosorb® hemoadsorption during cardiac bypass would reduce the incidence of moderate to massive bleeding in patients receiving ticagrelor within 48 hours prior to surgery.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Rouen, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Cytosorb® hemoadsorption cartridge is inserted into the cardiopulmonary bypass circuit immediately after the blood pump, with blood returned to the venous reservoir.
A sham tubing line, made of the same polymer and with the same diameter as the Cytosorb® tubing, is connected at the same location in the cardiopulmonary bypass circuit without a hemoadsorption cartridge.
Time frame: within the 48 first hours post-CPB
Incidence of a moderate, severe or massive bleeding defined by an UDPB (Universal Definition for Perioperative Bleeding) score ≥ 2/4 within the 48 first hours post-CPB.
Time frame: 48 hours after surgery
Bleeding severity categorized according to the four-level UDPB classification within 48 hours post-CPB
Time frame: 48 hours after surgery
The validated intraoperative bleeding severity scale defined by Lewis et al (Surgery 2017, doi: 10.1016/j.surg.2016.09.022)
The Lewis bleeding severity scale is scored based on visual assessment as follows:
0 = no bleeding
Based on qualitative description, it ranges from 0 (no bleeding) to 4 (life-threatening bleeding).
Based on visually estimated rate of blood loss (mL/min), it is scored from 0 (≤1 mL/min) to 4 (>50 mL/min).
Although the scale includes four subscales, a single overall subjective score ranging from 0 to 4 is assigned based on the combined interpretation of all subscales.
Time frame: 90 days
A surgical reintervention for any cause will be considered within 90 days.
Time frame: 90 days
Other hemorrhagic complications, including intracranial
Time frame: 90 days
The Major adverse cardiovascular events is defined as the composite outcome of myocardial infarction, cerebral stroke, acute heart failure, death
Time frame: 90 days
AKI will be defined as KDIGO ≥ 1; Acute respiratory failure will be defined by prolonged mechanical ventilation > 12 hours, reintubation, non-invasive ventilatory support or high flow nasal cannula therapy;Infection, sepsis and septic shock, will be defined by the 2026 surviving sepsis campaign
Time frame: 90 days
The EQ-5D-5L has 5 items with 5 likert levels leading to a score between 0% and 100% based on a specific population-dependent algorithm Higher scores indicate better quality of life (100% = very good health)
Time frame: Baseline to 90 days
Total number of red blood cell (RBC) units transfused within 90 days after baseline.
Time frame: Baseline to 90 days
Total number of fresh frozen plasma (FFP) units transfused within 90 days after baseline.
Time frame: Baseline to 90 days
Total dose of Prothrombin Complex Concentrate (PCC) administered within 90 days after baseline, reported in international units (IU).
Time frame: Baseline to 90 days
Total number of platelet units transfused within 90 days after baseline.
Time frame: Baseline to 90 days
Total dose of fibrinogen concentrate administered within 90 days after baseline, reported in grams (g).
Time frame: Baseline to 90 days
Total dose of activated factor VII administered within 90 days after baseline, reported in grams (g).
Contact information is provided by the study sponsor or research team.
University Hospital, Rouen
Other
Ticagrelor Hemoadsorption Using Cytosorb® for Reduction of Bleeding During Cardiac Surgery - TICAdSORB
Acronym: TICAdSORB
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