BleedingNCT05542277
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
A study testing ClearPlasma in people with Bleeding and Bypass Complication, run by PlasFree Ltd. at 8 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Bypass Complication, Valve Replacement
- What is being tested?
- ClearPlasma
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 8 Nov 2022to 9 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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;
Show all 16Show fewer
- 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*.
- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Czechia3 sites
Charles University Teaching Hospital
Hradec Králové, 50005
University Hospital Olomouc
Olomouc, 77900
University Hospital Ostrava
Ostrava, 70852
Israel3 sites
Wolfson Medical center
Holon, 5822012
Rabin Medical Center - Beilinson
Petah Tikva, 17000
Sheba Medical Center
Ramat Gan, 52621
Poland2 sites
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego w Poznaniu
Poznan
Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego Państwowy Instytut Badawczy
Warsaw
About this study
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.
Read the detailed 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.
- Conditions
- Bleeding, Bypass Complication, Valve Replacement
- Being tested
- ClearPlasma
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearPlasmaDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ClearPlasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 30 days
Secondary outcomes (13)
Transfusion- related SAE
Comparison of the number of transfusion- related SAEs between the groups. [time frame: discharge]obtained through filtration with ClearPlasma™ in patients after coronary artery bypass grafting or valve replacement surgery and to compare it to the same procedure carried out using FFP units.
Measured: 30 days
Hemoglobin levels
Comparison of hemoglobin levels drop between the groups [time frame: measured at patient's departure from the operating room/admitting to the ICU and compared to the lowest hemoglobin value until discharge]
Measured: 30 days
Post-operative blood loss
Post-operative blood loss (mL) within 12 hours after surgery, defined as total output of mediastinal and pleural chest tubes. [time frame: up to 12 hours after procedure]
Measured: 30 days
Total blood loss
Total blood loss, defined as total output of chest tubes from insertion till removal [time frame: drain removal]
Measured: 30 days
ClearPlasma
Ratio of bleeding events between the groups [time frame: discharge]
Measured: 30 days
bleeding events-
Ratio of bleeding events requiring re-intervention up to discharge [time frame: discharge]
Measured: 30 days
major bleeding
Ratio of major bleeding defined as blood loss greater than >1000 mL in first 12 h and/or need for surgical revision owing to bleeding; [time frame: discharge]
Measured: 30 days
Mortality
All-cause mortality[time frame: 30 days]
Measured: 30 days
In- hospital mortality
In- hospital mortality [time frame: discharge]
Measured: 30 days
Number of blood units transfused
The number of units of allogeneic blood products transfused until discharge [time frame: discharge]:
- Red blood cells (RBC) units transfused;
- Plasma (PDP/FFP) units transfused;
- Platelet concentrates units transfused
Measured: 30 days
Length of stay in the ICU
Length of stay in the ICU [Time Frame: discharge]
Measured: 30 days
Hospitalization Duration
Total length of hospitalization [Time Frame: discharge]
Measured: 30 days
Incidence of ischemic outcomes
Comparison of the incidence of ischemic outcomes defined as a composite of stroke, transient ischemic attack, acute myocardial infarction, PE and/or acute renal failure [time frame: discharge] Study Groups
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start8 Nov 2022
- Primary completion9 Mar 2025
- Study completion9 Mar 2025
Why it stopped: The study was stopped to evaluate the differences between the indications.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- PlasFree Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zeev Dvashi, Ph.D, Study director, Plas-Free LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542277
- Sponsor's protocol ID
- PLAS-01-2021
- Status last verified
- Dec 2023
- First submitted
- 19 Aug 2022
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: all data will be published in peer review article
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05542277
- Acronym / sponsor ID
- PLAS-01-2021
- Conditions
- Bleeding, Bypass Complication, Valve Replacement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped to evaluate the differences between the indications.
- Enrolment
- 130 participants (actual)
- Lead sponsor
- PlasFree Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 9 Mar 2025 (actual)
- Study completion
- 9 Mar 2025 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ClearPlasma | Experimental | Device: ClearPlasmaInvestigational Group (A): one-time infusion (up to 12 hours after surgery) of unlimited plasminogen depleted plasma PDP units generated by ClearPlasma™ device. |
| Control | Placebo comparator | Device: ClearPlasmaControl Group (B): one-time infusion (up to 12 hours) of unlimited regular plasma, Fresh frozen plasma (FFP) with mock ClearPlasma™ device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearPlasmaClearPlasma 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 | Device | ClearPlasma, Control |
Primary outcome
ClearPlasma efficacy
Time frame: 30 days
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]
13 secondary outcomes
Transfusion- related SAE
Time frame: 30 days
Hemoglobin levels
Time frame: 30 days
Post-operative blood loss
Time frame: 30 days
Total blood loss
Time frame: 30 days
ClearPlasma
Time frame: 30 days
bleeding events-
Time frame: 30 days
major bleeding
Time frame: 30 days
Mortality
Time frame: 30 days
In- hospital mortality
Time frame: 30 days
Number of blood units transfused
Time frame: 30 days
Length of stay in the ICU
Time frame: 30 days
Hospitalization Duration
Time frame: 30 days
Incidence of ischemic outcomes
Time frame: 30 days
Results and safety
The study was stopped early (reason given: The study was stopped to evaluate the differences between the indications.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Yes. all data will be published in peer review article
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeev Dvashi, Ph.D study director
Plas-Free LTD
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClearPlasma in people with Bleeding and Bypass Complication, run by PlasFree Ltd. at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Czechia, Israel, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped to evaluate the differences between the indications.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ClearPlasma efficacy (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.