Upper Gastrointestinal Bleeding (UGIB)CLearPlasmaNCT06761430
Evaluation of ClearPlasma in Patients With Upper Gastrointestinal Bleeding.
A study testing ClearPlasma in people with Upper Gastrointestinal Bleeding (UGIB), run by PlasFree Ltd. at 1 site in Italy.
Trial summary
Upper gastrointestinal hemorrhage (UGIH) is one of the most common gastrointestinal emergencies, and is associated with significant morbidity and mortality. Plas-Free aims to evaluate ClearPlasma safety in patients with UGIH. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Gastrointestinal Bleeding (UGIB)
- What is being tested?
- ClearPlasma
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteItaly
- Study dates
- 23 Dec 2019to 20 Mar 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients aged ≥ 18 and ≤ 80 years old. 2. Patients presenting with acute upper gastrointestinal hemorrhage (> 0.5 L), diagnosed by presence of blood in gastric lavage, hematemesis or melena within no longer than 24 h before enrolment.
- 3. Patients presenting with acute upper gastrointestinal hemorrhage (< 24 h) for which fresh frozen plasma (FFP) has been ordered.
- 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 the study protocol.
Who cannot join
- Patients who underwent a plasma infusion in the 30 days before enrolment. 2. Patients in a life-threatening condition at the time of enrolment (i.e. heart attack).
- 3. Patients who are hemodynamically unstable and required pressor administration at the time of enrolment (i.e. with hypovolemic shock) 4. Patients with known renal failure (creatinine clearance < 30 mL/min) at the time of enrolment.
- 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 measured body weight < 45 kg at the time of enrolment. 11. Patients with history of allergic reaction to plasma, polyethersyplone or polycarbonate.
- 12. Patients suffering from IgA deficiency at the time of enrolment. 13. Patients with history of hemorrhage while on anticoagulant treatment (warfarin, apixaban, rivaroxaban, dabigatran, low molecular weight heparin).
Show all 11Show fewer
- 14. Patients identified by the Investigator to have any underlying medical Clinicalconditions that may preclude conduct of study procedure (i.e. making the administration of study treatment hazardous) or obscure the interpretation of safety objectives.
- 15. Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
- 16. 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.
- 17. 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.
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Trial locations and contacts
1 site in 1 country.
Italy1 site
Area Medicina D'Urgenza e Pronto Soccorso Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Largo A. Gemelli, 800168 -
Rome
About this study
Official title: A PRE-MARKET, DUBLE CENTER, INTERNATIONAL, ONE-ARM, CONTROLLED, PROSPECTIVE CLINICAL INVESTIGATION ASSESSING THE SAFETY OF A CLASS IIb MEDICAL DEVICE (CLEARPLASMA™) FOR THE TREATMENT OF PATIENTS WITH ACUTE UPPER GASTROINTESTINAL HEMORRHAGE"
Upper gastrointestinal hemorrhage (UGIH) is one of the most common gastrointestinal emergencies, and is associated with significant morbidity and mortality. Plas-Free aims to evaluate ClearPlasma safety in patients with UGIH.
Read the detailed description
Upper gastrointestinal hemorrhage (UGIH) is one of the most common gastrointestinal emergencies, and is associated with significant morbidity and mortality. Acute upper gastrointestinal hemorrhage (AUGIH) management guidelines call for aggressive hemodynamic resuscitation, prevention and treatment of complications and treatment of bleeding, which generally includes endoscopic intervention and transfusion of appropriate blood components. However, in many cases, spontaneous hyperfibrinolysis occurs, jeopardizing pharmacological control of AUGIH. Antifibrinolytic drugs are considered effective in counteracting hyperfibrinolysis, but are associated with various side effects, such as neurotoxicity and accelerated fibrinolysis upon prolonged use.
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.
PlasFree 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 re-bleeding in Patients undergoing plasma transfusions.
- Conditions
- Upper Gastrointestinal Bleeding (UGIB)
- Being tested
- ClearPlasma
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearPlasmaDevice
ClearPlasmais an extra-corporeal plasma filtration device, designed to specifically extract plasminogen, a protein that drives fibrinolysis, from up to 250 mL of plasma. ClearPlasmaTM is a non-pyrogenic, sterile, single-use medical device.
| Study group | Role | What they receive |
|---|---|---|
| One-time infusion of up to two units of PDP obtained through filtration with ClearPlasma | Experimental | To assess the safety of a one-time infusion of up to two units of Plasminogen depleted Plasma (PDP) obtained through filtration with ClearPlasma in Patients with acute upper gastrointestinal bleeding. Receives: Device: ClearPlasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of severe adverse events
Number of severe adverse events (SAE) and/or adverse events (AE) compared to the gold standard.
Measured: 30 days
Secondary outcomes (1)
Thromboembolic Events
Venous thromboembolism (VTE) and/ or deep vein thrombosis (DVT) and/or pulmonary embolism (PE) compared to the gold standard.
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 posted7 Jan 2025
- Study start23 Dec 2019
- Primary completion4 Feb 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal Bleeding (UGIB)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- To assess the safety of a one-time infusion of up to two units of PDP obtained through filtration with ClearPlasma in the reduction of re-bleeding in Patients presenting with acute upper gastrointestinal hemorrhage
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- PlasFree Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761430
- Sponsor's protocol ID
- PLas-Free 2019-10-30_007461
- Other IDs
- DGDMF/P/I.5.I.M.2/2019/1319, MOH_2019-10-30_007461
- Acronym
- CLearPlasma
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PRE-MARKET, DUBLE CENTER, INTERNATIONAL, ONE-ARM, CONTROLLED, PROSPECTIVE CLINICAL INVESTIGATION ASSESSING THE SAFETY OF A CLASS IIb MEDICAL DEVICE (CLEARPLASMA™) FOR THE TREATMENT OF PATIENTS WITH ACUTE UPPER GASTROINTESTINAL HEMORRHAGE"
- ClinicalTrials.gov ID
- NCT06761430
- Acronym / sponsor ID
- CLearPlasma / PLas-Free 2019-10-30_007461
- Conditions
- Upper Gastrointestinal Bleeding (UGIB)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- PlasFree Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 7 Jan 2025 (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.
Upper gastrointestinal hemorrhage (UGIH) is one of the most common gastrointestinal emergencies, and is associated with significant morbidity and mortality. Plas-Free aims to evaluate ClearPlasma safety in patients with UGIH.
Detailed description
Upper gastrointestinal hemorrhage (UGIH) is one of the most common gastrointestinal emergencies, and is associated with significant morbidity and mortality. Acute upper gastrointestinal hemorrhage (AUGIH) management guidelines call for aggressive hemodynamic resuscitation, prevention and treatment of complications and treatment of bleeding, which generally includes endoscopic intervention and transfusion of appropriate blood components. However, in many cases, spontaneous hyperfibrinolysis occurs, jeopardizing pharmacological control of AUGIH. Antifibrinolytic drugs are considered effective in counteracting hyperfibrinolysis, but are associated with various side effects, such as neurotoxicity and accelerated fibrinolysis upon prolonged use.
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.
PlasFree 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 re-bleeding in Patients undergoing plasma transfusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To assess the safety of a one-time infusion of up to two units of PDP obtained through filtration with ClearPlasma in the reduction of re-bleeding in Patients presenting with acute upper gastrointestinal hemorrhage
| Arm | Type | Receives |
|---|---|---|
| One-time infusion of up to two units of PDP obtained through filtration with ClearPlasma | Experimental | Device: ClearPlasmaTo assess the safety of a one-time infusion of up to two units of Plasminogen depleted Plasma (PDP) obtained through filtration with ClearPlasma in Patients with acute upper gastrointestinal bleeding. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Patients aged ≥ 18 and ≤ 80 years old. 2. Patients presenting with acute upper gastrointestinal hemorrhage (> 0.5 L), diagnosed by presence of blood in gastric lavage, hematemesis or melena within no longer than 24 h before enrolment.
- 3. Patients presenting with acute upper gastrointestinal hemorrhage (< 24 h) for which fresh frozen plasma (FFP) has been ordered.
- 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 the study protocol.
Key exclusion criteria (11 listed)
- Patients who underwent a plasma infusion in the 30 days before enrolment. 2. Patients in a life-threatening condition at the time of enrolment (i.e. heart attack).
- 3. Patients who are hemodynamically unstable and required pressor administration at the time of enrolment (i.e. with hypovolemic shock) 4. Patients with known renal failure (creatinine clearance < 30 mL/min) at the time of enrolment.
- 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 measured body weight < 45 kg at the time of enrolment. 11. Patients with history of allergic reaction to plasma, polyethersyplone or polycarbonate.
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 |
|---|---|---|
| ClearPlasmaClearPlasmais an extra-corporeal plasma filtration device, designed to specifically extract plasminogen, a protein that drives fibrinolysis, from up to 250 mL of plasma. ClearPlasmaTM is a non-pyrogenic, sterile, single-use medical device. | Device | One-time infusion of up to two units of PDP obtained through filtration with ClearPlasma |
Primary outcome
Number of severe adverse events
Time frame: 30 days
Number of severe adverse events (SAE) and/or adverse events (AE) compared to the gold standard.
1 secondary outcome
Thromboembolic Events
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClearPlasma in people with Upper Gastrointestinal Bleeding (UGIB), run by PlasFree Ltd. at 1 site in Italy.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of severe adverse events (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 7 Jan 2025.