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.
Patient or patient's representative having read and understood the information letter and signed the consent form
Age ≥ 18 y/o
Ticagrelor administration within 48 hours prior to surgery
Cardiac surgery with cardiac bypass
Concomitant antiplatelet drugs or ongoing anticoagulants other than aspirin and heparin
Ongoing systemic infection (including active endocarditis)
Ongoing treatment with an antibiotic or antifungal at high risk of removal by Cytosorb®: teicoplanin, vancomycin, linezolid, gentamycin, amphotericin B liposomal, azole drugs or fluconazole
Ongoing treatment with an anticonvulsant at high risk of removal by Cytosorb®: phenytoin, phenobarbital or valproic acid.
Parallel
Device: Cytosorb hemoadsorption
DeviceThe Cytosorb® hemoadsorption cartridge is inserted into the cardiopulmonary bypass circuit immediately after the blood pump, with blood returned to the venous reservoir.
Device: Sham extracorporeal circuit
DeviceA 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.
benefit of Cytosorb® in reducing perioperative bleeding of cardiac surgery
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.
compare the distribution of bleeding severity between groups
Bleeding severity categorized according to the four-level UDPB classification within 48 hours post-CPB
compare the intensity of intraoperative bleeding
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 1. = ooze or intermittent flow 2. = continuous flow 3. = controllable spurting and/or overwhelming flow 4. = unidentified or inaccessible spurting or gush Based on anatomic appearance, it is scored from 0 (no bleeding) to 4 (central arterial- or venous-like 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.
compare the surgical reintervention rate due to bleeding between groups
A surgical reintervention for any cause will be considered within 90 days.
compare between groups, the risk of other hemorrhagic complications
Other hemorrhagic complications, including intracranial
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