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

11. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

232

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: eksperimentell arm
Enhet: 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-komparator: control arm
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
benefit of Cytosorb® in reducing perioperative bleeding of cardiac surgery
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
compare the distribution of bleeding severity between groups
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 90 days
Other hemorrhagic complications, including intracranial
90 days
compare between groups the risk of major adverse cardiovascular events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline to 90 days
Total dose of activated factor VII administered within 90 days after baseline, reported in grams (g).
Baseline to 90 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Rouen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. mars 2030

Studiet fullført (Antatt)

1. mars 2030

Datoer for studieregistrering

Først innsendt

18. august 2026

Først innsendt som oppfylte QC-kriteriene

11. september 2026

Først lagt ut (Faktiske)

16. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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