Phase
Condition
Lung Injury
Respiratory Failure
Acute Respiratory Distress Syndrome (Ards)
Treatment
PrismaLung+
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient age is ≥ 18 years old
Patient is expected to receive ECCO2R for a minimum of 24 hours
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
- 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:
Patients body weight < 30 kg
Patients with a contraindication for systemic anticoagulation with heparin
Patients with a platelet count < 50,000/µL
Patients on MV > 7 days
Patients with very severe, or stage 4 (as per GOLD staging System) chronicobstructive pulmonary disease (COPD)
Current or history of heparin-induced thrombocytopenia
Patients who are pregnant and/or breastfeeding
Patients not expected to survive the duration of the planned study treatment period (24 hours)
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
Connect with a study center
Baxter Investigational Site
Besançon, 25030
FranceSite Not Available
Baxter Investigational Site
Colombes, 92700
FranceSite Not Available
Baxter Investigational Site
Creteil, 94010
FranceSite Not Available
Baxter Investigational Site
Lille, 59037
FranceSite Not Available
Baxter Investigational Site
Marseille, 13354
FranceSite Not Available
Baxter Investigational Site
Montpellier, 34295
FranceSite Not Available
Baxter Investigational Site
Paris, 75651
FranceSite Not Available
Baxter Investigational Site
Strasbourg, 67098
FranceSite Not Available
Baxter Investigational Site
Vandœuvre-lès-Nancy, 54511
FranceSite Not Available
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