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

Last updated: June 11, 2025
Sponsor: PlasFree Ltd.
Overall Status: Terminated

Phase

N/A

Condition

Heart Valve Disease

Treatment

ClearPlasma

Clinical Study ID

NCT05542277
PLAS-01-2021
  • Ages > 18
  • All Genders

Study Summary

Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding. To address this unmet need, PLAS-FREE LTD has developed ClearPlasma™, a single-use, extracorporeal plasma filtration device which extracts plasminogen from plasma to reduce fibrinolysis. The resulting plasminogen-depleted plasma (PDP) is expected to reduce risk of fibrinolysis and bleeding in patients undergoing plasma transfusions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged ≥ 18 years

  2. Patients undergoing isolated coronary artery bypass grafting or valve replacementsurgeries with a cardiopulmonary bypass

  3. Patients that need at least 2 units of plasma transfusion according to thephysician's decision.

  4. Patients understanding the nature of the study and providing their informed consentto participation;

  5. Patients willing and able to attend the follow-up visits and procedures foreseen bystudy protocol.

Exclusion

  • 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 thetime 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 monthsbefore the enrolment;

  7. Patients with increased risk of blood clotting, according to Investigator'sjudgement;

  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 orpolycarbonate;

  11. Patients suffering from known IgA deficiency at the time of enrolment;

  12. Patients identified by the Investigator to have any underlying medical conditionsthat may preclude conduct of study procedure (i.e. making the administration ofstudy treatment hazardous) or obscure the interpretation of safety objectives;

  13. Patients who are participating or have participated in other clinical studies withinthe 30 days before the study enrolment.

  14. Women who are pregnant or breast-feeding or who wish to become pregnant during theperiod of the clinical investigation and for 3 months later;

  15. Female Patients of childbearing age (less than 12 months after the last menstrualcycle) 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.

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: ClearPlasma
Phase:
Study Start date:
November 08, 2022
Estimated Completion Date:
March 09, 2025

Study Description

Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding. Bleeding complications are associated with worse clinical outcomes, including a higher risk of infection, ischemic events attributable to hypo-perfusion (e.g., myocardial infarction, acute kidney injury), in-hospital mortality, and transfusion-related adverse events. Additionally, bleeding complications are an important driver of blood product utilization in cardiac surgery. Coagulopathy and bleeding after cardiac surgery are often a multifactorial problem, thus there is unmet need to find new technologies that can give better care to these bleeding patients. In 2016, it was estimated that one million people throughout the world undergo cardiac surgery each year. Most of these surgeries are Coronary artery bypass grafting and valves replacement. Coronary artery bypass grafting (CABG) is still the most commonly performed cardiac surgery procedure worldwide, representing annual volumes of approximately 200,000 isolated cases in the US and an average incidence rate of 62 per 100,000 inhabitants in western European countries. Aortic valve replacement is procedure that treat diseases affecting the aortic valve, one of four valves that control blood flow through the heart. In the United States, it is estimated that 2.5% of the general population, 8.5% of those 65-74 years of age and 13.2% of those ≥75 years of age have moderate to severe valvular diseases. These surgeries are commonly done in the western countries, however, the ability to halt the bleed remain challenge for most clinicians. Failed or delayed treatment of a massive bleeding can result in irreversible end-organ damage (e.g., renal failure), cardiovascular events (e.g., stroke, myocardial injury) or death, accompanied by significantly increased costs.

Fibrin clot breakdown is actively mediated by plasmin, a serine protease which cleaves fibrin. Administration of plasma depleted of plasminogen, the precursor of plasmin, may shift the balance towards coagulation.

PLAS-FREE LTD has developed ClearPlasma™, a single-use, extracorporeal plasma filtration device which extracts plasminogen from plasma to reduce fibrinolysis. The resulting plasminogen-depleted plasma (PDP) is expected to reduce risk of fibrinolysis and bleeding in patients undergoing plasma transfusions.

Connect with a study center

  • Charles University Teaching Hospital

    Hradec Králové, 50005
    Czechia

    Site Not Available

  • University Hospital Olomouc

    Olomouc, 77900
    Czechia

    Site Not Available

  • University Hospital Ostrava

    Ostrava, 70852
    Czechia

    Site Not Available

  • Wolfson Medical center

    Holon, 5822012
    Israel

    Site Not Available

  • Rabin Medical Center - Beilinson

    Petah Tikva, 17000
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu

    Poznań,
    Poland

    Site Not Available

  • Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego Państwowy Instytut Badawczy

    Warszawa,
    Poland

    Site Not Available

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