Hemolung RAS Registry Program

HL-CA-1600, Hemolung RAS Registry. A Retrospective Registry Involving Voluntary Reporting of De-identified, Standard of Care Data Following the Commercial Use of the Hemolung Respiratory Assist System (RAS)

The purpose of the Hemolung RAS Registry Program is to collect retrospective, de-identified, standard of care data following the commercial use of the Hemolung RAS.

Study Overview

• Status: Unknown
• Conditions: Acute Hypercapnic Respiratory Failure

Detailed Description

ALung's post-market Hemolung RAS Registry Program provides a continuum for measuring the Hemolung RAS effectiveness and safety in a real-world setting beyond the results reported in pre-market clinical feasibility studies. The Hemolung RAS Registry Program is part of ALung's 1) evaluation of clinical evidence throughout the life cycle of the product, 2) longer term residual risk assessment of the product, and 3) commitment to maintain quality systems and integrate continuous quality improvements in the product.

On a voluntary basis, participating physicians and institutional staff enter de-identified data online in the secure, password protected, regulatory-compliant Hemolung RAS Registry Portal in a retrospective manner following a patient's ICU discharge, status at 28 days post-Hemolung therapy, or death whichever is earlier. There is no requirement to collect and report data outside of standard of care. The program's methodology, data monitoring and statistical analysis plan is consistent with this type of initiative in a real-world setting.

• Study Type: Observational
• Enrollment (Anticipated): 99

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Severe COPD or ARDS

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of days in the ICU	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Number of days on Hemolung therapy	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Incidents	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Outcome at 28 days	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient mobility on Hemolung	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Blood product usage and hematologic effects on Hemolung	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Arterial blood gas changes on Hemolung	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Ventilatory mode and setting changes on Hemolung	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
CO2 removal and blood flow performance	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Hemolung-assisted weaning	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.

Collaborators and Investigators

• Sponsor: Alung Technologies
• Investigators: Study Director: Nausherwan Burki, MD, PhD, ALung Technologies, Inc.

Publications and helpful links

Helpful Links

• Hemolung RAS Registry Program Home Page

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 14, 2013
• First Posted (Estimate): May 17, 2013

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: HL-CA-1600