Cardiac SurgeryTICAdSORBNCT07822620
Ticagrelor Hemoadsorption Using Cytosorb® for Reduction of Bleeding During Cardiac Surgery
A study testing Device: Cytosorb hemoadsorption in people with Cardiac Surgery, run by University Hospital, Rouen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Device: Cytosorb hemoadsorption
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patient affiliated with, or beneficiary of a social security (health insurance) category.
- 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):
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- 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
- negative blood pregnancy test by b-HCG at inclusion.
- Women permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
- 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.
Who cannot join
- 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.
- 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))
- Cardiac surgery for ventricle assistance device or transplantation
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- Preoperative critical state
- Chronic pathology with life expectancy less than 1 month
- Pregnant or breastfeeding women and women of child-bearing age not using effective means of contraception
- Absence of affiliation to a social security program
- Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision
- Person consenting to the research participating having participated to another trial within a period of one week
- Person participating to another interventional research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Rouen
Rouen
BESNIER, +33232881705, Emmanuel.Besnier@chu-rouen.fr
BESNIER
About this study
Official title: 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%.
Read more
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.
- Conditions
- Cardiac Surgery
- Being tested
- Device: Cytosorb hemoadsorption, Device: Sham extracorporeal circuit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Cytosorb hemoadsorptionDevice
The 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 circuitDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Not described Receives: Device: Device: Cytosorb hemoadsorption |
| control arm | Sham comparator | Not described Receives: Device: Device: Sham extracorporeal circuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the 48 first hours post-CPB
Secondary outcomes (13)
compare the distribution of bleeding severity between groups
Bleeding severity categorized according to the four-level UDPB classification within 48 hours post-CPB
Measured: 48 hours after surgery
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
- = ooze or intermittent flow
- = continuous flow
- = controllable spurting and/or overwhelming flow
- = 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.
Measured: 48 hours after surgery
compare the surgical reintervention rate due to bleeding between groups
A surgical reintervention for any cause will be considered within 90 days.
Measured: 90 days
compare between groups, the risk of other hemorrhagic complications
Other hemorrhagic complications, including intracranial
Measured: 90 days
compare between groups the risk of major adverse cardiovascular events
The Major adverse cardiovascular events is defined as the composite outcome of myocardial infarction, cerebral stroke, acute heart failure, death
Measured: 90 days
compare between groups, the risk of any complication in the composite outcome of acute kidney injury
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
Measured: 90 days
compare quality of life between groups
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)
Measured: 90 days
Red blood cell transfusion at 90 days
Total number of red blood cell (RBC) units transfused within 90 days after baseline.
Measured: Baseline to 90 days
Fresh frozen plasma transfusion at 90 days
Total number of fresh frozen plasma (FFP) units transfused within 90 days after baseline.
Measured: Baseline to 90 days
Prothrombin complex concentrate use at 90 days
Total dose of Prothrombin Complex Concentrate (PCC) administered within 90 days after baseline, reported in international units (IU).
Measured: Baseline to 90 days
Platelet transfusion at 90 days
Total number of platelet units transfused within 90 days after baseline.
Measured: Baseline to 90 days
Fibrinogen concentrate administration at 90 days
Total dose of fibrinogen concentrate administered within 90 days after baseline, reported in grams (g).
Measured: Baseline to 90 days
Activated factor VII administration at 90 days
Total dose of activated factor VII administered within 90 days after baseline, reported in grams (g).
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822620
- Sponsor's protocol ID
- 2023/0300/HP
- Other IDs
- 2025-A02958-41
- Acronym
- TICAdSORB
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor Hemoadsorption Using Cytosorb® for Reduction of Bleeding During Cardiac Surgery - TICAdSORB
- ClinicalTrials.gov ID
- NCT07822620
- Acronym / sponsor ID
- TICAdSORB / 2023/0300/HP
- Conditions
- Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Device: Device: Cytosorb hemoadsorption |
| control arm | Sham comparator | Device: Device: Sham extracorporeal circuit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Patient affiliated with, or beneficiary of a social security (health insurance) category.
Key exclusion criteria (13 listed)
- 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.
- 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))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Cytosorb hemoadsorptionThe Cytosorb® hemoadsorption cartridge is inserted into the cardiopulmonary bypass circuit immediately after the blood pump, with blood returned to the venous reservoir. | Device | experimental arm |
| Device: Sham extracorporeal circuitA 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. | Device | control arm |
Primary outcome
benefit of Cytosorb® in reducing perioperative bleeding of cardiac surgery
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.
13 secondary outcomes
compare the distribution of bleeding severity between groups
Time frame: 48 hours after surgery
compare the intensity of intraoperative bleeding
Time frame: 48 hours after surgery
compare the surgical reintervention rate due to bleeding between groups
Time frame: 90 days
compare between groups, the risk of other hemorrhagic complications
Time frame: 90 days
compare between groups the risk of major adverse cardiovascular events
Time frame: 90 days
compare between groups, the risk of any complication in the composite outcome of acute kidney injury
Time frame: 90 days
compare quality of life between groups
Time frame: 90 days
Red blood cell transfusion at 90 days
Time frame: Baseline to 90 days
Fresh frozen plasma transfusion at 90 days
Time frame: Baseline to 90 days
Prothrombin complex concentrate use at 90 days
Time frame: Baseline to 90 days
Platelet transfusion at 90 days
Time frame: Baseline to 90 days
Fibrinogen concentrate administration at 90 days
Time frame: Baseline to 90 days
Activated factor VII administration at 90 days
Time frame: Baseline to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Cytosorb hemoadsorption in people with Cardiac Surgery, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BESNIER (+33232881705, Emmanuel.Besnier@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
benefit of Cytosorb® in reducing perioperative bleeding of cardiac surgery (time frame: within the 48 first hours post-CPB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.