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
Stopped: The study was stopped to evaluate the differences between the indications.
Czechia, Israel130 participantsStarted 2022-11-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients aged ≥ 18 years
âś“. Patients undergoing isolated coronary artery bypass grafting or valve replacement surgeries with a cardiopulmonary bypass
âś“. Patients that need at least 2 units of plasma transfusion according to the physician's decision.
âś“. Patients understanding the nature of the study and providing their informed consent to participation;
âś“. Patients willing and able to attend the follow-up visits and procedures foreseen by study protocol.
Exclusion criteria
âś•. Patients who underwent a plasma infusion in the 30 days before enrolment;
âś•. Patients in a life-threatening condition at the time of enrolment;
âś•. Patients who are hemodynamically unstable and required pressor administration at the time of enrolment (i.e. hypovolemic shock, cardiogenic shock);
âś•. Transfusion of cryoprecipitate during procedure.