Acute Hypercapnic Respiratory FailureNCT01855815
Hemolung RAS Registry Program
An observational study of Acute Hypercapnic Respiratory Failure, run by Alung Technologies.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Hypercapnic Respiratory Failure
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe COPD or ARDS
About this study
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)
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.
Read the 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.
- Conditions
- Acute Hypercapnic Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days in the ICU
Measured: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Number of days on Hemolung therapy
Measured: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Incidents
Measured: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Outcome at 28 days
Measured: 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
Measured: 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
Measured: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Arterial blood gas changes on Hemolung
Measured: 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
Measured: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
CO2 removal and blood flow performance
Measured: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Hemolung-assisted weaning
Measured: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alung Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nausherwan Burki, MD, PhD, Study director, ALung Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855815
- Sponsor's protocol ID
- HL-CA-1600
- Status last verified
- Jan 2019
- First submitted
- 13 May 2013
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01855815
- Acronym / sponsor ID
- HL-CA-1600
- Conditions
- Acute Hypercapnic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Alung TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe COPD or ARDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of days in the ICU
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Number of days on Hemolung therapy
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Incidents
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Outcome at 28 days
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
6 secondary outcomes
Patient mobility on Hemolung
Time frame: 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
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Arterial blood gas changes on Hemolung
Time frame: 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
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
CO2 removal and blood flow performance
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Hemolung-assisted weaning
Time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nausherwan Burki, MD, PhD study director
ALung Technologies, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Hypercapnic Respiratory Failure, run by Alung Technologies.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days in the ICU (time frame: Patient data will only be reported for up to a maximum of 28 days from Hemolung therapy initiation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.