A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+

Recruiting now · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome, Acute Kidney Injury

In brief

PrismaLung+ is a sterile, single-use medical device aimed at performing partial removal of carbon dioxide (CO2) from the patient's venous blood via diffusion through a membrane. The goal of this prospective, open label, randomized controlled study is to evaluate the efficacy and safety of PrismaLung+ on extracorporeal carbon dioxide removal (ECCO2R) in critically ill patients under invasive mechanical ventilation (IMV). Patients will be randomized to receive either IMV combined with ECCO2R (using PrismaLung+) in the study group or IMV alone in the control group, at a ratio of 2:1.

Key facts

Study ID

NCT07326215

Run by

Vantive Health LLC

People needed

99

Starts

2025-12-11

Expected to finish

2026-08-31

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old.
• Invasive mechanical ventilation patients with PaCO2 > 50 mmHg and pH < 7.4 under LPV strategy (RR < 25/min, DP < 15 cmH2O).
• Expected to be able to tolerate ECCO2R for a minimum of 2h.
• Patients signed a written informed consent; if the right to consent cannot be exercised due to loss of decision-making ability or impairment of consciousness, the legal representative or immediate family member must sign the informed consent document after fully understanding the research content.

You may not qualify if…

• Body weight < 30 kg.
• Has a contraindication for systemic anticoagulation with heparin according to the Investigator.
• Patient unable to establish extracorporeal circulation access or has a high risk of establishing such access, as judged by the Investigator.
• Allergic to the investigational device/tubing, and/or to the CRRT filters/tubing if combined with CRRT treatment.
• Expected to require extracorporeal membrane oxygenator (ECMO) treatment within 24h after enrollment.
• Patient's primary disease is expected to worsen rapidly or require other surgical intervention within 24h after enrollment.
• Diagnosed as brain dead or in a vegetative state.
• Pregnant and/or breastfeeding.
• Plans to participate in other device studies within 30 days before screening or during the study period or has completed any clinical drug study within 5 half lives of the investigational drug.
• Patients is considered as unsuitable for participating in the study, as judged by the Investigator.

Where it is running

• ZhongShan Hospital Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• The University of Hong Kong-Shenzhen Hospital — Shenzhen, Guangdong, China
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China
• The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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