NCT01855815

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

6.7 years

First QC Date

May 13, 2013

Last Update Submit

January 24, 2019

Conditions

Acute Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • 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.

  • +1 more secondary outcomes

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Nausherwan Burki, MD, PhD

    ALung Technologies, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 17, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

January 28, 2019

Record last verified: 2019-01