Evaluation of ClearPlasma in Patients With Upper Gastrointestinal Bleeding.

NCT06761430 | Completed DMC

• 3 other identifiers: PLas-Free 2019-10-30_007461DGDMF/P/I.5.I.M.2/2019/1319MOH_2019-10-30_007461
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Gastrointestinal Bleeding (UGIB)

Outcome Measures

Primary Outcomes (1)

• Number of severe adverse events

  Number of severe adverse events (SAE) and/or adverse events (AE) compared to the gold standard.

  30 days

Secondary Outcomes (1)

• Thromboembolic Events

  30 days

Study Arms (1)

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.

Device: ClearPlasma

Interventions

ClearPlasma DEVICE

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.

One-time infusion of up to two units of PDP obtained through filtration with ClearPlasma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Patients presenting with acute upper gastrointestinal hemorrhage (\< 24 h) for which fresh frozen plasma (FFP) has been ordered.
• \. 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 the study protocol.

You may not qualify if:

• 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).
• \. 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.
• \. Patients suffering from Hemophilia A or B. 6. 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. 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.
• \. 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).
• \. 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.
• \. 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.

Sponsors & Collaborators

• PlasFree Ltd.: lead

Study Sites (1)

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

Rome, Italy

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: in this study there is no Masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: January 7, 2025
• Study Start: December 23, 2019
• Primary Completion: February 4, 2021
• Study Completion: March 20, 2021
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)