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Blood filter attached to Heart-Lung machine aims to stop ticagrelor bleeding
NCT ID NCT07822620
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Patients who take ticagrelor and then need heart bypass surgery face a higher risk of serious bleeding because the drug blocks platelets and transfusions cannot reverse it. The TICAdSORB trial tests whether a blood-filtering cartridge called Cytosorb, placed in the heart-lung machine during surgery, can remove ticagrelor from the blood and lower bleeding. Researchers randomly assign 232 adults who took ticagrelor within 48 hours before surgery to receive either the Cytosorb filter or a sham tubing line without the cartridge. The main measure is how many patients have moderate to massive bleeding in the first 48 hours after bypass.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cytosorb hemoadsorption cartridge, a blood-filtering device added to the heart-lung machine
- What this could lead to
- If it works, this could give surgeons a way to operate sooner on patients who took ticagrelor, without waiting days for the drug to clear and risking another heart event.
- What could go wrong
- The trial may show the filter does not reduce bleeding enough to matter, or that it removes other blood components with unwanted effects. Results in this specific surgery setting may not apply to other operations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 232 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Rouen
Rouen, France
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