Hemolung RAS Registry Program

Acute Hypercapnic Respiratory Failure Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01855815
• Other study ID #: HL-CA-1600
• Status: Active, not recruiting
• Start date: April 2013
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Alung Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Related Conditions & MeSH terms

• Acute Hypercapnic Respiratory Failure
• Hypercapnia
• Respiratory Insufficiency

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alung Technologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days in the ICU		Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Primary	Number of days on Hemolung therapy		Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Primary	Incidents		Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Primary	Outcome at 28 days		Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Secondary	Patient mobility on Hemolung		Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Secondary	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.
Secondary	Arterial blood gas changes on Hemolung		Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Secondary	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.
Secondary	CO2 removal and blood flow performance		Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Secondary	Hemolung-assisted weaning		Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.