Clinical trial NCT01855815: Hemolung RAS Registry Program
Official title: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Hypercapnic Respiratory Failure
Lead sponsor: Alung Technologies
Sponsor class: INDUSTRY
First posted: 2013-05-17
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severe COPD or ARDS

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.


Primary outcomes:
measure: Number of days in the ICU
timeFrame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
measure: Number of days on Hemolung therapy
timeFrame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
measure: Incidents
timeFrame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
measure: Outcome at 28 days
timeFrame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Secondary outcomes:
measure: Patient mobility on Hemolung
timeFrame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
measure: Blood product usage and hematologic effects on Hemolung
timeFrame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
measure: Arterial blood gas changes on Hemolung
timeFrame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
measure: Ventilatory mode and setting changes on Hemolung
timeFrame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
measure: CO2 removal and blood flow performance
timeFrame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
measure: Hemolung-assisted weaning
timeFrame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Other outcomes:
Locations:
Study officials:
affiliation: ALung Technologies, Inc.
name: Nausherwan Burki, MD, PhD
role: STUDY_DIRECTOR
References: