Actively Recruiting
A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+
Led by Vantive Health LLC · Updated on 2026-02-17
99
Participants Needed
10
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients on invasive mechanical ventilation with partial pressure of carbon dioxide (PaCO2) greater than 50 mmHg and blood pH less than 7.4 under lung protective ventilation strategy (respiratory rate less than 25/min, driving pressure less than 15 cmH2O)
- Expected to tolerate extracorporeal carbon dioxide removal (ECCO2R) for at least 2 hours
- Signed informed consent by patient or legal representative if patient is unable to consent
You will not qualify if you...
- Body weight less than 30 kg
- Contraindication to systemic anticoagulation with heparin as determined by the Investigator
- Unable or high risk to establish extracorporeal circulation access as judged by the Investigator
- Allergy to PrismaLung+ device or tubing, or to CRRT filters/tubing if combined with CRRT
- Expected to need extracorporeal membrane oxygenation (ECMO) within 24 hours after enrollment
- Primary disease expected to worsen rapidly or require surgery within 24 hours after enrollment
- Diagnosed brain death or vegetative state
- Pregnant or breastfeeding
- Participation in other device studies within 30 days before screening or during the study, or recent participation in clinical drug studies
- Considered unsuitable for study participation by the Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Not Yet Recruiting
2
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510630
Not Yet Recruiting
3
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China, 518053
Not Yet Recruiting
4
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Not Yet Recruiting
5
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Not Yet Recruiting
6
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
7
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
8
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
9
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
10
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
Research Team
G
Global CORP Clinical Trials Disclosure
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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