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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 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-06-15

No results posted yet for this 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.

Conditions

  • Bleeding
  • Bypass Complication
  • Valve Replacement

Interventions

DEVICE

ClearPlasma

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

Sponsors & Collaborators

  • PlasFree Ltd.

    lead INDUSTRY

Principal Investigators

  • Zeev Dvashi, Ph.D · Plas-Free LTD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2025-03-09
Completion
2025-03-09
FDA Device
Yes

Countries

  • Czechia
  • Israel
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05542277 on ClinicalTrials.gov