Post-Market Study of Low-flow ECCO2R Using PrismaLung+

Last updated: October 25, 2024
Sponsor: Baxter Healthcare Corporation
Overall Status: Completed

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Acute Respiratory Distress Syndrome (Ards)

Treatment

PrismaLung+

Clinical Study ID

NCT04617093
BXU542357
  • Ages > 18
  • All Genders

Study Summary

PrismaLung+ is indicated to provide extracorporeal carbon dioxide removal (ECCO2R) as a stand-alone therapy or in combination with continuous renal replacement therapy (CRRT). This study is intended for patients with increased levels of Carbon Dioxide (CO2) in their blood and ≥ 18 years old, and will treat patients with mild or moderate acute respiratory distress syndrome (ARDS) using PrismaLung+. The study will assess tidal volume reduction and confirm the safety of PrismaLung+.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient age is ≥ 18 years old

  2. Patient is expected to receive ECCO2R for a minimum of 24 hours

  3. Patient has mild or moderate ARDS according to the Berlin definition:

  • 100 mm Hg < PaO2/FiO2 ≤ 300 mm Hg, with PEEP ≥ 5 cm H2O, and

  • Bilateral lung opacities not fully explained by effusions, lobar/lung collapse,or nodules, and

  • Respiratory failure not fully explained by cardiac failure or fluid overload

  1. Written informed consent to participate in the study from the patient, if possible,or from the identified authorized representative if the patient is unable to provideconsent.

Exclusion

Exclusion Criteria:

  1. Patients body weight < 30 kg

  2. Patients with a contraindication for systemic anticoagulation with heparin

  3. Patients with a platelet count < 50,000/µL

  4. Patients on MV > 7 days

  5. Patients with very severe, or stage 4 (as per GOLD staging System) chronicobstructive pulmonary disease (COPD)

  6. Current or history of heparin-induced thrombocytopenia

  7. Patients who are pregnant and/or breastfeeding

  8. Patients not expected to survive the duration of the planned study treatment period (24 hours)

  9. Patients currently participating in another interventional clinical study, except ifthe patient is in an investigational medicinal product study, already in follow-upwithout further administration of study drug, and has not received anyinvestigational medicinal product within 5 half-lives

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: PrismaLung+
Phase:
Study Start date:
April 30, 2021
Estimated Completion Date:
January 10, 2024

Connect with a study center

  • Baxter Investigational Site

    Besançon, 25030
    France

    Site Not Available

  • Baxter Investigational Site

    Colombes, 92700
    France

    Site Not Available

  • Baxter Investigational Site

    Creteil, 94010
    France

    Site Not Available

  • Baxter Investigational Site

    Lille, 59037
    France

    Site Not Available

  • Baxter Investigational Site

    Marseille, 13354
    France

    Site Not Available

  • Baxter Investigational Site

    Montpellier, 34295
    France

    Site Not Available

  • Baxter Investigational Site

    Paris, 75651
    France

    Site Not Available

  • Baxter Investigational Site

    Strasbourg, 67098
    France

    Site Not Available

  • Baxter Investigational Site

    Vandœuvre-lès-Nancy, 54511
    France

    Site Not Available

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