Using ClearPlasma™ to reduce bleeding in heart surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Zeev Dvashi, Ph.D
• Email: zeev@plas-free.com
• Phone: +972-4-6098615

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.