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

Not Applicable

Completed

• Conditions: Mild to Moderate Acute Respiratory Distress Syndrome
• Interventions: Device: PrismaLung+

• Registration Number: NCT04617093
• Lead Sponsor: Baxter Healthcare Corporation

Brief 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+.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-05
• Study Start: 2021-04-30
• Primary Completion: 2023-12-05
• Study Completion: 2024-01-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Total Patient Population	PrismaLung+	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.

Primary Outcome Measures

Name	Time	Method
Adverse Device Effect (ADE)	Day 1 to Day 28	This includes study device and study procedure related adverse events.
Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation	8 and 24 hours following ECCO2R initiation	Must maintain PaCO2 \< 50 mmHg. ULPV is defined as defined as a tidal volume (VT) of 4 mL/kg of predicted body weight.
Adverse Events related to study procedure	Day 1 to Day 28	Adverse events related to the study procedure (ECCO2R or ECCO2R in combination with CRRT), irrespective of relatedness to the device.
Adverse Events leading to study withdrawal	Day 1 to Day 28	Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users or other persons, in the context of a clinical investigation leading to study withdrawal.
Adverse events of special interest (AESIs)	Day 1 to Day 28	The AESI's for this study include significant bleeding events (i.e. require administration of ≥ 1 unit of packed red blood cells (pRBC) or result in a related SAE).
Adverse Events related to study device	Day 1 to Day 28	Adverse event related to the use of a study device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the study device.; This definition includes any event resulting from use error or from intentional misuse of the study device.

Trial Locations

Locations (1)

Baxter Investigational Site; 🇫🇷 Vandœuvre-lès-Nancy, France