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Ticagrelor Hemoadsorption Using Cytosorb® for Reduction of Bleeding During Cardiac Surgery (TICAdSORB)

11 september 2026 bijgewerkt door: University Hospital, Rouen

Ticagrelor Hemoadsorption Using Cytosorb® for Reduction of Bleeding During Cardiac Surgery - TICAdSORB

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

232

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Patient or patient's representative having read and understood the information letter and signed the consent form
  2. Age ≥ 18 y/o
  3. Ticagrelor administration within 48 hours prior to surgery
  4. Cardiac surgery with cardiac bypass
  5. Patient affiliated with, or beneficiary of a social security (health insurance) category.

  6. Women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile):

    1. with effective contraception (Cf. CTCG) (progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide) since 1 month, during study period
    2. negative blood pregnancy test by b-HCG at inclusion.
  7. Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
  8. Postmenopausal women: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

Exclusion Criteria:

  1. Concomitant antiplatelet drugs or ongoing anticoagulants other than aspirin and heparin
  2. Ongoing systemic infection (including active endocarditis)
  3. 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
  4. Ongoing treatment with an anticonvulsant at high risk of removal by Cytosorb®: phenytoin, phenobarbital or valproic acid.
  5. Contraindications to Cytosorb® (known preoperative platelet count < 20 000/mm3, Sickle cell disease crisis, history to heparin-induced thrombopenia, body mass index ≥ 40 kg/m², hypersensitivity to a component, Any pre-existing contraindication to extracorporeal therapy (CPB))
  6. Cardiac surgery for ventricle assistance device or transplantation
  7. Preoperative critical state
  8. Chronic pathology with life expectancy less than 1 month
  9. Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception
  10. Absence of affiliation to a social security program
  11. Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision
  12. Person consenting to the research participating having participated to another trial within a period of one week
  13. Person participating to another interventional research

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: experimentele arm
Apparaat: Device: Cytosorb hemoadsorption
The Cytosorb® hemoadsorption cartridge is inserted into the cardiopulmonary bypass circuit immediately after the blood pump, with blood returned to the venous reservoir.
Sham-vergelijker: control arm
Apparaat: Device: Sham extracorporeal circuit
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
benefit of Cytosorb® in reducing perioperative bleeding of cardiac surgery
Tijdsspanne: 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.
within the 48 first hours post-CPB

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
compare the distribution of bleeding severity between groups
Tijdsspanne: 48 hours after surgery
Bleeding severity categorized according to the four-level UDPB classification within 48 hours post-CPB
48 hours after surgery
compare the intensity of intraoperative bleeding
Tijdsspanne: 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

  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.
48 hours after surgery
compare the surgical reintervention rate due to bleeding between groups
Tijdsspanne: 90 days
A surgical reintervention for any cause will be considered within 90 days.
90 days
compare between groups, the risk of other hemorrhagic complications
Tijdsspanne: 90 days
Other hemorrhagic complications, including intracranial
90 days
compare between groups the risk of major adverse cardiovascular events
Tijdsspanne: 90 days
The Major adverse cardiovascular events is defined as the composite outcome of myocardial infarction, cerebral stroke, acute heart failure, death
90 days
compare between groups, the risk of any complication in the composite outcome of acute kidney injury
Tijdsspanne: 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
90 days
compare quality of life between groups
Tijdsspanne: 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)
90 days
Red blood cell transfusion at 90 days
Tijdsspanne: Baseline to 90 days
Total number of red blood cell (RBC) units transfused within 90 days after baseline.
Baseline to 90 days
Fresh frozen plasma transfusion at 90 days
Tijdsspanne: Baseline to 90 days
Total number of fresh frozen plasma (FFP) units transfused within 90 days after baseline.
Baseline to 90 days
Prothrombin complex concentrate use at 90 days
Tijdsspanne: Baseline to 90 days
Total dose of Prothrombin Complex Concentrate (PCC) administered within 90 days after baseline, reported in international units (IU).
Baseline to 90 days
Platelet transfusion at 90 days
Tijdsspanne: Baseline to 90 days
Total number of platelet units transfused within 90 days after baseline.
Baseline to 90 days
Fibrinogen concentrate administration at 90 days
Tijdsspanne: Baseline to 90 days
Total dose of fibrinogen concentrate administered within 90 days after baseline, reported in grams (g).
Baseline to 90 days
Activated factor VII administration at 90 days
Tijdsspanne: Baseline to 90 days
Total dose of activated factor VII administered within 90 days after baseline, reported in grams (g).
Baseline to 90 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Rouen

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 maart 2030

Studie voltooiing (Geschat)

1 maart 2030

Studieregistratiedata

Eerst ingediend

18 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 september 2026

Eerst geplaatst (Werkelijk)

16 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 september 2026

Laatste update ingediend die voldeed aan QC-criteria

11 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2023/0300/HP
  • 2025-A02958-41 (Register-ID: RCB)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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