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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01855815

Enrollment

Registered

2013-05-17

Start date

2013-04-30

Completion date

2019-12-31

Last updated

2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hypercapnic Respiratory Failure

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Design outcomes

Primary

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

Measure	Time frame
CO2 removal and blood flow performance	Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Patient mobility on Hemolung	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.
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.

Outcome results