Evaluation of ClearPlasma in Patients With Upper Gastrointestinal Bleeding. (CLearPlasma)

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.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Bleeding (UGIB)
• Intervention / Treatment: Device: ClearPlasma

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Area Medicina D'Urgenza e Pronto Soccorso Fondazione Policlinico Universitario A. Gemelli IRCCS Università Cattolica del Sacro Cuore Largo A. Gemelli, 800168 -

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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).

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.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One-time infusion of up to two units of PDP obtained through filtration with ClearPlasma; 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.	Device: ClearPlasma; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of severe adverse events	Number of severe adverse events (SAE) and/or adverse events (AE) compared to the gold standard.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thromboembolic Events	Venous thromboembolism (VTE) and/ or deep vein thrombosis (DVT) and/or pulmonary embolism (PE) compared to the gold standard.	30 days

Collaborators and Investigators

• Sponsor: PlasFree Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2019
• Primary Completion (Actual): February 4, 2021
• Study Completion (Actual): March 20, 2021

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: PLas-Free 2019-10-30_007461; DGDMF/P/I.5.I.M.2/2019/1319 (Registry Identifier: ITALIAN MOH); MOH_2019-10-30_007461 (Registry Identifier: Israeli MOH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No