Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatment of Patients With Acute Upper Gastrointestinal Hemorrhage.

  • STATUS
    Recruiting
  • days left to enroll
    90
  • participants needed
    80
  • sponsor
    PlasFree Ltd.
Updated on 2 May 2022

Summary

Pre-market, multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation of a Class IIb Investigational Medical Device, in which Patients presenting with acute upper gastrointestinal hemorrhage (AUGIH) and due to undergo a plasma transfusion, will be randomized to receive a one-time infusion (up to 8 hours) of up to two 250 mL units of plasminogen-depleted plasma (PDP) or fresh-frozen plasma (FFP).

In case of transfusions needing more than two units, the third unit and above will consist in regular plasma for both treatment groups. Patients will be continuously monitored for 8 hours following the transfusion, and will be assessed between 8-12 hours after plasma transfusion or the following morning (the earlier of the two options), between 24-48 hours after plasma transfusion or at discharge (the earlier of the two options) and after 30+/-3 days after transfusion.

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.

The Primary Objective of this trial is to assess the safety profile of a one-time infusion of up to two units of PDP obtained through filtration with ClearPlasma in Patients presenting with acute upper gastrointestinal hemorrhage and to compare it to the same procedure carried out using FFP units.

The Secondary Objective of this trial is to assess the efficacy 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 (as a measure of the performance of ClearPlasma) and to compare it to the same procedure carried out using FFP units.

Details
Condition Acute Upper Gastrointestinal Hemorrhage, Acute Upper Gastrointestinal Bleeding
Treatment Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device), Regular fresh-frozen plasma (not treated)
Clinical Study IdentifierNCT04174989
SponsorPlasFree Ltd.
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female Patients
Patients aged ≥ 18 and ≤ 80 years old
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 study protocol

Exclusion Criteria

Patients who underwent a plasma infusion in the 30 days before enrolment
Patients in a life-threatening condition at the time of enrolment
Patient on anticoagulant therapy at the time of enrolment
Patients with known renal failure (creatinine clearance < 30 mL/min) at the time of enrolment
Patients suffering of Hemophilia A or B
Patients suffering of venous and arterial thromboembolic events within 3 months before the enrolment
Patients with history of allergic reaction to plasma, polyethersyplone or polycarbonate
Patients suffering of IgA deficiency at the time of enrolment
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 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 24 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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