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

NCT05542277 | Terminated DMC FDA Device

• 1 other identifier: PLAS-01-2021
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 8

Brief 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.

Conditions

Bleeding; Bypass Complication; Valve Replacement

Outcome Measures

Primary Outcomes (1)

• ClearPlasma efficacy

  Post-operative blood loss (mL) within 24 hours after surgery, defined as total output of mediastinal and pleural chest tubes. \[time frame: up to 24 hours after procedure\]

  30 days

Secondary Outcomes (13)

• Transfusion- related SAE

  30 days

• Hemoglobin levels

  30 days

• Post-operative blood loss

  30 days

• Total blood loss

  30 days

• ClearPlasma

  30 days

Study Arms (2)

ClearPlasma

EXPERIMENTAL

Investigational Group (A): one-time infusion (up to 12 hours after surgery) of unlimited plasminogen depleted plasma PDP units generated by ClearPlasma™ device.

Device: ClearPlasma

Control

PLACEBO COMPARATOR

Control Group (B): one-time infusion (up to 12 hours) of unlimited regular plasma, Fresh frozen plasma (FFP) with mock ClearPlasma™ device.

Device: ClearPlasma

Interventions

ClearPlasma DEVICE

ClearPlasma ClearPlasma™ is an extra-corporeal plasma filtration device, designed to specifically extract plasminogen, a protein that drives fibrinolysis, from up to 250 mL of plasma. ClearPlasma™ is a non-pyrogenic, sterile, single-use medical device

ClearPlasma; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who underwent a plasma infusion in the 30 days before enrolment;
• Patients in a life-threatening condition at the time of enrolment;
• Patients who are hemodynamically unstable and required pressor administration at the time of enrolment (i.e. hypovolemic shock, cardiogenic shock);
• Transfusion of cryoprecipitate during procedure.
• Patients suffering from Hemophilia A or B;
• Patients suffering from venous and arterial thromboembolic events within 3 months before the enrolment;
• Patients with increased risk of blood clotting, according to Investigator's judgement;
• Patients with fluid accumulation in the brain at the time of enrolment.
• Patients with retinal thrombosis at the time of enrolment;
• Patients with history of allergic reaction to plasma, polyethersyplone or polycarbonate;
• Patients suffering from known IgA deficiency at the time of enrolment;
• 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;
• Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
• 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;
• Female Patients of childbearing age (less than 12 months after the last menstrual cycle) who do not use adequate contraception\*.

Sponsors & Collaborators

• PlasFree Ltd.: lead

Study Sites (8)

Charles University Teaching Hospital

Hradec Králové, 50005, Czechia

Location

University Hospital Olomouc

Olomouc, 77900, Czechia

Location

University Hospital Ostrava

Ostrava, 70852, Czechia

Location

Wolfson Medical center

Holon, 5822012, Israel

Location

Rabin Medical Center - Beilinson

Petah Tikva, 17000, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu

Poznan, Poland

Location

Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego Państwowy Instytut Badawczy

Warsaw, Poland

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeev Dvashi, Ph.D

  Plas-Free LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After all applicable screening assessments have been performed, patients who have met all inclusion criteria and none of the exclusion criteria will be randomly allocated to one of the two treatment groups (with ratio 1:1) and will receive a unique computer-generated randomization number. Site stratified block randomization will be used during the study. Blocks length will have random length (e.g., 4, 6, 8). In order to reduce bias as much as possible, the trial will be double-blinded, keeping Sponsor, all patients and the Investigator blinded to the treatment. The randomization list will not be available to blinded personnel (such as Principal Investigator) involved in the conduct and evaluation of the trial until the trial database is locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, international, double-blind, randomized, controlled, prospective, clinical investigation, in which Patients undergoing Coronary Artery Bypass Grafting or valve replacement surgeries with a cardiopulmonary bypass, required plasma transfusion, will be randomized to receive a one-time infusion (up to 12 hours) of PDP (group A) or FFP (group B) with unlimited number of plasma units. The administration of plasma needs to be in line with the clinical practice and doctor decision. Furthermore, the main point is the patients with CABG/VRS that lost significant blood and need transfusion. Patients will be continuously monitored during transfusion and during stay in ICU. The assessment and additional test will be done at the admission to the ICU, 12 hours (±1) after procedure, 24 hours (±1) after procedure, 48 hours (±2) after procedure, at the discharge and 30±3 days after procedure.

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: September 15, 2022
• Study Start: November 8, 2022
• Primary Completion: March 9, 2025
• Study Completion: March 9, 2025
• Last Updated: June 15, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after the study will end

Locations

IL (3); PL (2); CZ (3)