Using ClearPlasma™ to reduce bleeding in heart surgery patients

A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasma™) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement

This study is testing if a new device called ClearPlasma™ can help reduce bleeding during heart surgery for patients getting bypass or valve replacement.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: PlasFree Ltd. (industry)
• Locations: 8 sites (Hradec Králové and 7 other locations)
• Trial ID: NCT05542277 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the safety and effectiveness of ClearPlasma™, a medical device designed to filter plasma and reduce fibrinolysis in patients undergoing coronary artery bypass grafting or valve replacement. The study is a multi-center, international, double-blind, randomized controlled trial that aims to address the significant issue of bleeding complications in cardiac surgery, which affects a substantial percentage of patients. By utilizing plasminogen-depleted plasma, the study seeks to improve clinical outcomes and reduce the need for blood product utilization during and after surgery.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are scheduled for isolated coronary artery bypass grafting or valve replacement and require plasma transfusions.

Not a fit: Patients who are in a life-threatening condition, hemodynamically unstable, or have certain bleeding disorders like hemophilia will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly decrease bleeding complications and improve recovery outcomes for patients undergoing cardiac surgery.

How similar studies have performed: While the use of plasma filtration devices is a novel approach, similar studies addressing bleeding complications in cardiac surgery have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Patients aged ≥ 18 years
2. Patients undergoing isolated coronary artery bypass grafting or valve replacement surgeries with a cardiopulmonary bypass
3. Patients that need at least 2 units of plasma transfusion according to the physician's decision.
4. Patients understanding the nature of the study and providing their informed consent to participation;
5. Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol.

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Exclusion Criteria:

1. Patients who underwent a plasma infusion in the 30 days before enrolment;
2. Patients in a life-threatening condition at the time of enrolment;
3. Patients who are hemodynamically unstable and required pressor administration at the time of enrolment (i.e. hypovolemic shock, cardiogenic shock);
4. Transfusion of cryoprecipitate during procedure.
5. Patients suffering from Hemophilia A or B;
6. Patients suffering from venous and arterial thromboembolic events within 3 months before the enrolment;
7. Patients with increased risk of blood clotting, according to Investigator's judgement;
8. Patients with fluid accumulation in the brain at the time of enrolment.
9. Patients with retinal thrombosis at the time of enrolment;
10. Patients with history of allergic reaction to plasma, polyethersyplone or polycarbonate;
11. Patients suffering from known IgA deficiency at the time of enrolment;
12. Patients identified by the Investigator to have any underlying medical conditions that may preclude conduct of study procedure (i.e. making the administration of study treatment hazardous) or obscure the interpretation of safety objectives;
13. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
14. Women who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical investigation and for 3 months later;
15. Female Patients of childbearing age (less than 12 months after the last menstrual cycle) who do not use adequate contraception\*.

Methods at low risk of contraceptive failure (less than 1% per year) when used consistently, including: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), some intra-uterine devices.

Where this trial is running

Hradec Králové and 7 other locations

• Charles University Teaching Hospital — Hradec Králové, Czechia (RECRUITING)
• University Hospital Olomouc — Olomouc, Czechia (RECRUITING)
• University Hospital Ostrava — Ostrava, Czechia (RECRUITING)
• Wolfson Medical center — Holon, Israel (RECRUITING)
• Rabin Medical Center - Beilinson — Petah Tikva, Israel (RECRUITING)
• Sheba Medical Center — Ramat Gan, Israel (RECRUITING)
• Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu — Poznań, Poland (RECRUITING)
• Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego Państwowy Instytut Badawczy — Warszawa, Poland (RECRUITING)

Study contacts

• Study coordinator: Zeev Dvashi, Ph.D

Conditions: Bleeding, Bypass Complication, Valve Replacement