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

Vantive Health LLC

Status: Completed

Conditions: Mild to Moderate Acute Respiratory Distress Syndrome

Treatments: Device: PrismaLung+

Study type: Interventional

Funder types: Industry

Identifiers

NCT04617093

BXU542357

Details and patient eligibility

About

PrismaLung+ is intended to provide extracorporeal carbon dioxide removal (ECCO2R) as a standalone therapy or in combination with continuous renal replacement therapy (CRRT). This study is a multi-centre, prospective, open-label, single-arm study. Adult patients with mild or moderate acute respiratory distress syndrome (ARDS) requiring mechanical ventilation were planned to receive ultra-lung protective ventilation (ULPV) associated with ECCO2R using PrismaLung+. The study will assess the capability of PrismaLung+ to allow ULPV, defined as a tidal volume (VT) of 4 mL/kg of predicted body weight, and confirm the safety of PrismaLung+.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

4. 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 provide consent.

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) chronic obstructive 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 if the patient is in an investigational medicinal product study, already in follow-up without further administration of study drug, and has not received any investigational medicinal product within 5 half-lives

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Total Patient Population

Experimental group

Description:

The planned PrismaLung+ treatment period for this study is 24 hours. Neuromuscular blockade and sedation will be required for the first 24 hours of ECCO2R treatment and thereafter, will be used at the discretion of the attending physician. Patients will require systemic anticoagulation with heparin during ECCO2R treatment. Blood warming during ECCO2R treatment will occur using the TherMax blood warmer.

Treatment:

Device: PrismaLung+