Acute Exacerbation of COPDVENT-AVOIDNCT03255057
Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD
A study testing Hemolung Respiratory Assist System and Invasive mechanical ventilation in people with Acute Exacerbation of COPD, run by Alung Technologies at 32 sites in United States.
Trial summary
This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Acute Exacerbation of COPD
- What is being tested?
- Hemolung Respiratory Assist System and Invasive mechanical ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 32 sitesUnited States
- Study dates
- 18 Feb 2018to 17 Aug 2022
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years
- Confirmed diagnosis of underlying COPD or ACOS (Asthma-COPD Overlap Syndrome)
- Experiencing acute hypercapnic respiratory failure
- Informed consent from patient or legally authorized representative
- Meets one of the three following criteria:
- Is at high risk of requiring intubation and invasive mechanical ventilation (MV) after at least one hour on NIV due to one or more of the following:
Show all 17Show fewer
- Respiratory acidosis (arterial pH <= 7.25) despite NIV
- Worsening hypercapnia or respiratory acidosis relative to baseline blood gases
- No improvement in PaCO2 relative to baseline blood gases and presence of moderate or severe dyspnea
- Presence of tachypnea > 30 breaths per minute
- Intolerance of NIV with failure to improve or worsening acidosis, dyspnea or work of breathing
- OR
- After starting NIV with a baseline arterial pH ≤ 7.25, shows signs of progressive clinical decompensation manifested by decreased mental capacity, inability to tolerate NIV, or increased or decreased respiratory rate in setting of worsened or unchanged acidosis.
- OR
- Currently intubated and receiving Invasive MV, meeting both of the following:
- Intubated for ≤ 5 days (from intubation to time of consent), AND
- Has failed a spontaneous breathing trial OR is deemed not suitable for a spontaneous breathing trial (SBT) OR is deemed not suitable for extubation
Who cannot join
- DNR/DNI order
- Hemodynamic instability (mean arterial pressure < 60 mmHg) despite infusion of vasoactive drugs
- Acute coronary syndrome
- Current presence of severe pulmonary edema due to Congestive Heart Failure
- PaO2/FiO2 < 120 mmHg on PEEP >/= 5 cmH2O
- Presence of bleeding diathesis or other contraindication to anticoagulation therapy
Show all 21Show fewer
- Platelet count >= 100,000/mm3 not requiring daily transfusions to maintain platelet count above 100,000/mm3 at time of screening
- Hemoglobin >= 7.0 gm% not requiring daily transfusions to maintain hemoglobin count above 7.0 gm% at time of screening, and no active major bleeding
- Unable to protect airway (e.g. unable to generate cough or clear secretions) or significant weakness or paralysis of respiratory muscles due to causes unrelated to acute exacerbation of COPD
- Cerebrovascular accident, intracranial bleed, head injury or other neurological disorder likely to adversely affect ventilation or airway protection.
- Hypersensitivity to heparin or history of previous heparin-induced thrombocytopenia (HIT Type II)
- Presence of a significant pneumothorax or bronchopleural fistula
- Current uncontrolled, major psychiatric disorder
- Current participation in any other interventional clinical study
- Pregnant women (women of child bearing potential require a pregnancy test)
- Neutropenic (absolute neutrophil count < 1,00mm3, not transient) related to the presence or treatment of a malignancy; recent bone marrow transplant (within prior 8 months); current, uncontrolled AIDS.
- Fulminant liver failure
- Known vascular abnormality or condition which could complicate or prevent successful Hemolung Catheter insertion
- Terminal patients not expected to survive current hospitalization
- Requiring continuous home ventilation via a tracheostomyy
- Any disease or condition that, in the judgment of the investigator, either places the subject at undue risk of complications from the Hemolung RAS device, or may reduce the subject's likelihood of benefitting from therapy with the Hemolung RASr
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Albany Medical Center
Albany, New York, 12208-3412
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Tufts Medical Center
Boston, Massachusetts, 02111
University of Virginia Medical Center
Charlottesville, Virginia, 22903
UT Erlanger
Chattanooga, Tennessee, 37403
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Denver Health Medical Center
Denver, Colorado, 80204
Duke University Medical Center
Durham, North Carolina, 27710
Inova Health Care Services
Falls Church, Virginia, 22042
University of Florida - Health Shands
Gainesville, Florida, 32610
Spectrum Health Hospitals
Grand Rapids, Michigan, 49504
UT McGovern Medical School Memorial Hermann
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Lexington VA Healthcare
Lexington, Kentucky, 40502
University of Louisville
Louisville, Kentucky, 40202
WellStar Kennestone Regional Medical Center
Marietta, Georgia, 30060
Memphis VA Medical Center
Memphis, Tennessee, 38104
Minneapolis Heart
Minneapolis, Minnesota, 55407
Rutgers-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08902
Northwell Health
New Hyde Park, New York, 11040
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032
Christiana Care Health System
Newark, Delaware, 19718
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Rhode Island Hospital
Providence, Rhode Island, 02903
UC Davis Medical Group
Sacramento, California, 95817
LSU Health Shreveport
Shreveport, Louisiana, 71103
Baylor Scott and White Memorial Hospital
Temple, Texas, 76508
About this study
Official title: A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support
This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It is hypothesized that the Hemolung RAS can be safely used to avoid or reduce time on invasive mechanical ventilation compared to COPD patients treated with standard-of-care mechanical ventilation alone. Eligible patients will be randomized to receive lung support with either the Hemolung RAS plus standard-of-care mechanical ventilation, or standard-of-care mechanical ventilation alone.
Read the detailed description
The Hemolung RAS provides low-flow ECCO2R using a single, 15.5 French dual-lumen catheter inserted percutaneously in the femoral or jugular vein. Low-flow ECCO2R offers an alternative or supplement to invasive mechanical ventilation (MV) for patients suffering from acute, reversible, hypercapnic respiratory failure. In contrast to invasive MV, low-flow ECCO2R provides partial ventilatory support independently of the lungs. The rationale for this study is that low-flow ECCO2R with the Hemolung RAS can be used to provide supplemental CO2 removal in COPD patients experiencing acute hypercapnic respiratory failure to either avoid or reduce time on invasive MV. In this patient population, avoidance or reduced time on invasive MV may have significant clinical benefit in reducing the many complications associated with invasive MV. The major complication risks of low-flow ECCO2R are associated with central venous catheterization and the need for anticoagulation during treatment. This study is designed to evaluate the safety and efficacy of Hemolung RAS plus standard-of-care as compared to standard-of-care alone.
- Conditions
- Acute Exacerbation of COPD
- Being tested
- Hemolung Respiratory Assist System, Invasive mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemolung Respiratory Assist SystemDevice
Also called Low-flow extracorporeal carbon dioxide removal, ECCO2R, Hemolung RAS, Hemolung
Treatment with a medical device called the Hemolung RAS. The Hemolung RAS includes three components: the Hemolung Controller, the Hemolung Cartridge, and the Hemolung Catheter. The intervention is use of the Hemolung RAS to provide partial lung support for acute hypercapnic lung failure by filtering carbon dioxide from venous blood using a central venous catheter through which venous blood is pumped at flows of 350-550 milliliters per minute to and from an external circuit containing a hollow fiber membrane blood gas exchanger (with heparin-coated fibers) integrated with a centrifugal pump.
Invasive mechanical ventilationDevice
Lung support for acute lung failure applied with a mechanical ventilation device that uses positive pressure to mechanically inflate the lungs and facilitate exhalation via an endotracheal tube or tracheotomy.
| Study group | Role | What they receive |
|---|---|---|
| Hemolung plus SOC IMV | Experimental | Low-flow ECCO2R with the Hemolung Respiratory Assist System as an alternative or adjunct to standard-of-care (SOC) invasive mechanical ventilation (IMV) Receives: Device: Hemolung Respiratory Assist System; Device: Invasive mechanical ventilation |
| SOC IMV | Active comparator | Standard-of-care (SOC) invasive mechanical ventilation (IMV) alone Receives: Device: Invasive mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of time in the first five days following randomization that a patient is free of Invasive MV and alive
Statistically analyzed as Ventilator-Free Days during the 5 days from randomization (VFD-5)
Measured: 5 days
Secondary outcomes (11)
Physiologic benefit
Based on blood gases and concomitant ventilation parameters
Measured: Time to extubation from first intubation up to 60 days from randomization
Avoidance of intubation
Incidence of subjects who did not require intubation at any time during their primary hospital admission for the exacerbation for which they were enrolled in the study.
Measured: Within 60 days from randomization
Ability to communicate by speaking
Number of days from randomization to end of treatment (end of Invasive MV in Control Arm and end of Hemolung treatment in Investigational Arm) subject is able to communicate by speaking
Measured: Randomization to end of treatment or 14 days, whichever is sooner
Ability to eat and drink orally
Number of days from randomization to end of treatment (end of Invasive MV in Control Arm and end of Hemolung treatment in Investigational Arm) subject is able to eat and drink orally
Measured: Randomization to end of treatment or 14 days, whichever is sooner
ICU Mobility
Ability of subject to mobilize in bed and out of bed while in Intensive Care as assessed using ICU Mobility Score (IMS)
Measured: Randomization to end of treatment or 14 days, whichever is sooner
Daily dose of sedatives, analgesics, and paralytics while in ICU
A qualify of life measure for subjects while in ICU measured by reported concomitant medications while in ICU.
Measured: From randomization to ICU discharge up to 60 days from randomization
Incidence of new tracheotomies
Incidence of new tracheotomies
Measured: Within 60 days from randomization
Adverse events
All Serious Adverse Events (SAE) from randomization to 60 days and non-serious adverse events from randomization to ICU discharge or 30 days, whichever is sooner (adjudicated by the Clincal Events Committee)
Measured: Within 60 days from randomization
All-cause in-hospital mortality
Subject death from any cause while still admitted to hospital for the acute exacerbation for which they were enrolled in the study.
Measured: Within 60 days from randomization
All-cause (health-related) mortality at 60 days from randomization
Incidence of health-related deaths at 60 days from randomization, regardless of subject location at time of death.
Measured: Within 60 days from randomization
Incidence of failed extubations
Incidence of re-intubation within 48 hours of extubation for original exacerbation
Measured: Within 60 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start18 Feb 2018
- Primary completion10 Aug 2022
- Study completion17 Aug 2022
Why it stopped: Lack of enrollment post COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-center, randomized, controlled, two-arm, open-label, adaptive, two-strata, pivotal trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alung Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Hill, MD, Principal investigator, Tufts University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255057
- Sponsor's protocol ID
- HL-CA-5000
- Acronym
- VENT-AVOID
- Status last verified
- Oct 2022
- First submitted
- 9 Aug 2017
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Burki NK, Mani RK, Herth FJF, Schmidt W, Teschler H, Bonin F, Becker H, Randerath WJ, Stieglitz S, Hagmeyer L, Priegnitz C, Pfeifer M, Blaas SH, Putensen C, Theuerkauf N, Quintel M, Moerer O. A novel extracorporeal CO(2) removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013 Mar;143(3):678-686. doi: 10.1378/chest.12-0228.
PubMed 23460154Duggal A, Conrad SA, Barrett NA, Saad M, Cheema T, Pannu S, Romero RS, Brochard L, Nava S, Ranieri VM, May A, Brodie D, Hill NS; VENT-AVOID Investigators. Extracorporeal Carbon Dioxide Removal to Avoid Invasive Ventilation During Exacerbations of Chronic Obstructive Pulmonary Disease: VENT-AVOID Trial - A Randomized Clinical Trial. Am J Respir Crit Care Med. 2024 Mar 1;209(5):529-542. doi: 10.1164/rccm.202311-2060OC.
PubMed 38261630Stokes JW, Gannon WD, Rice TW. Extracorporeal Carbon Dioxide Removal or Extracorporeal Membrane Oxygenation: Why Should We Care? Crit Care Med. 2021 May 1;49(5):e546-e547. doi: 10.1097/CCM.0000000000004844. No abstract available.
PubMed 33854019
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support
- ClinicalTrials.gov ID
- NCT03255057
- Acronym / sponsor ID
- VENT-AVOID / HL-CA-5000
- Conditions
- Acute Exacerbation of COPD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment post COVID-19 pandemic
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Alung TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 21 Aug 2017 (actual)
- 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.
This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It is hypothesized that the Hemolung RAS can be safely used to avoid or reduce time on invasive mechanical ventilation compared to COPD patients treated with standard-of-care mechanical ventilation alone. Eligible patients will be randomized to receive lung support with either the Hemolung RAS plus standard-of-care mechanical ventilation, or standard-of-care mechanical ventilation alone.
Detailed description
The Hemolung RAS provides low-flow ECCO2R using a single, 15.5 French dual-lumen catheter inserted percutaneously in the femoral or jugular vein. Low-flow ECCO2R offers an alternative or supplement to invasive mechanical ventilation (MV) for patients suffering from acute, reversible, hypercapnic respiratory failure. In contrast to invasive MV, low-flow ECCO2R provides partial ventilatory support independently of the lungs. The rationale for this study is that low-flow ECCO2R with the Hemolung RAS can be used to provide supplemental CO2 removal in COPD patients experiencing acute hypercapnic respiratory failure to either avoid or reduce time on invasive MV. In this patient population, avoidance or reduced time on invasive MV may have significant clinical benefit in reducing the many complications associated with invasive MV. The major complication risks of low-flow ECCO2R are associated with central venous catheterization and the need for anticoagulation during treatment. This study is designed to evaluate the safety and efficacy of Hemolung RAS plus standard-of-care as compared to standard-of-care alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multi-center, randomized, controlled, two-arm, open-label, adaptive, two-strata, pivotal trial
| Arm | Type | Receives |
|---|---|---|
| Hemolung plus SOC IMV | Experimental | Device: Hemolung Respiratory Assist System, Device: Invasive mechanical ventilationLow-flow ECCO2R with the Hemolung Respiratory Assist System as an alternative or adjunct to standard-of-care (SOC) invasive mechanical ventilation (IMV) |
| SOC IMV | Active comparator | Device: Invasive mechanical ventilationStandard-of-care (SOC) invasive mechanical ventilation (IMV) alone |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 40 years
- Confirmed diagnosis of underlying COPD or ACOS (Asthma-COPD Overlap Syndrome)
- Experiencing acute hypercapnic respiratory failure
- Informed consent from patient or legally authorized representative
- Meets one of the three following criteria:
Key exclusion criteria (21 listed)
- DNR/DNI order
- Hemodynamic instability (mean arterial pressure < 60 mmHg) despite infusion of vasoactive drugs
- Acute coronary syndrome
- Current presence of severe pulmonary edema due to Congestive Heart Failure
- PaO2/FiO2 < 120 mmHg on PEEP >/= 5 cmH2O
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemolung Respiratory Assist SystemAlso: Low-flow extracorporeal carbon dioxide removal, ECCO2R, Hemolung RAS, HemolungTreatment with a medical device called the Hemolung RAS. The Hemolung RAS includes three components: the Hemolung Controller, the Hemolung Cartridge, and the Hemolung Catheter. The intervention is use of the Hemolung RAS to provide partial lung support for acute hypercapnic lung failure by filtering carbon dioxide from venous blood using a central venous catheter through which venous blood is pumped at flows of 350-550 milliliters per minute to and from an external circuit containing a hollow fiber membrane blood gas exchanger (with heparin-coated fibers) integrated with a centrifugal pump. | Device | Hemolung plus SOC IMV |
| Invasive mechanical ventilationLung support for acute lung failure applied with a mechanical ventilation device that uses positive pressure to mechanically inflate the lungs and facilitate exhalation via an endotracheal tube or tracheotomy. | Device | Hemolung plus SOC IMV, SOC IMV |
Primary outcome
The amount of time in the first five days following randomization that a patient is free of Invasive MV and alive
Time frame: 5 days
Statistically analyzed as Ventilator-Free Days during the 5 days from randomization (VFD-5)
11 secondary outcomes
Physiologic benefit
Time frame: Time to extubation from first intubation up to 60 days from randomization
Avoidance of intubation
Time frame: Within 60 days from randomization
Ability to communicate by speaking
Time frame: Randomization to end of treatment or 14 days, whichever is sooner
Ability to eat and drink orally
Time frame: Randomization to end of treatment or 14 days, whichever is sooner
ICU Mobility
Time frame: Randomization to end of treatment or 14 days, whichever is sooner
Daily dose of sedatives, analgesics, and paralytics while in ICU
Time frame: From randomization to ICU discharge up to 60 days from randomization
Incidence of new tracheotomies
Time frame: Within 60 days from randomization
Adverse events
Time frame: Within 60 days from randomization
All-cause in-hospital mortality
Time frame: Within 60 days from randomization
All-cause (health-related) mortality at 60 days from randomization
Time frame: Within 60 days from randomization
Incidence of failed extubations
Time frame: Within 60 days from randomization
Results and safety
The study was stopped early (reason given: Lack of enrollment post COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Background: PubMed 23460154Burki NK, Mani RK, Herth FJF, Schmidt W, Teschler H, Bonin F, Becker H, Randerath WJ, Stieglitz S, Hagmeyer L, Priegnitz C, Pfeifer M, Blaas SH, Putensen C, Theuerkauf N, Quintel M, Moerer O. A novel extracorporeal CO(2) removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013 Mar;143(3):678-686. doi: 10.1378/chest.12-0228.
- Derived from this study: PubMed 38261630Duggal A, Conrad SA, Barrett NA, Saad M, Cheema T, Pannu S, Romero RS, Brochard L, Nava S, Ranieri VM, May A, Brodie D, Hill NS; VENT-AVOID Investigators. Extracorporeal Carbon Dioxide Removal to Avoid Invasive Ventilation During Exacerbations of Chronic Obstructive Pulmonary Disease: VENT-AVOID Trial - A Randomized Clinical Trial. Am J Respir Crit Care Med. 2024 Mar 1;209(5):529-542. doi: 10.1164/rccm.202311-2060OC.
- Derived from this study: PubMed 33854019Stokes JW, Gannon WD, Rice TW. Extracorporeal Carbon Dioxide Removal or Extracorporeal Membrane Oxygenation: Why Should We Care? Crit Care Med. 2021 May 1;49(5):e546-e547. doi: 10.1097/CCM.0000000000004844. No abstract available.
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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.
Nicholas Hill, MD principal investigator
Tufts University Medical Center
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemolung Respiratory Assist System and Invasive mechanical ventilation in people with Acute Exacerbation of COPD, run by Alung Technologies at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. 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: stopped early, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Lack of enrollment post COVID-19 pandemic). 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?
The amount of time in the first five days following randomization that a patient is free of Invasive MV and alive (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03255057, which also lists 3 linked publications.
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 14 Oct 2022.