Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation of COPD

NCT03255057 | Terminated DMC FDA Device

• 1 other identifier: HL-CA-5000
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 32

Brief 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 (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.

Conditions

Acute Exacerbation of COPD

Outcome Measures

Primary Outcomes (1)

• 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)

  5 days

Secondary Outcomes (11)

• Physiologic benefit

  Time to extubation from first intubation up to 60 days from randomization

• Avoidance of intubation

  Within 60 days from randomization

• Ability to communicate by speaking

  Randomization to end of treatment or 14 days, whichever is sooner

• Ability to eat and drink orally

  Randomization to end of treatment or 14 days, whichever is sooner

• ICU Mobility

  Randomization to end of treatment or 14 days, whichever is sooner

Other Outcomes (9)

• Time to ICU discharge

  From ICU admission to discharge up to 60 days from randomization

• Time to hospital discharge

  From hospital admission to discharge up to 60 days from randomization

• Time on ventilatory support

  Randomization to end of Hemolung an Invasive MV for initial exacerbation up to 60 days from randomization

Study Arms (2)

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)

Device: Hemolung Respiratory Assist System; Device: Invasive mechanical ventilation

SOC IMV

ACTIVE COMPARATOR

Standard-of-care (SOC) invasive mechanical ventilation (IMV) alone

Device: Invasive mechanical ventilation

Interventions

Hemolung Respiratory Assist System DEVICE

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.

Also known as: Low-flow extracorporeal carbon dioxide removal, ECCO2R, Hemolung RAS, Hemolung, Respiratory dialysis, Lung dialysis

Hemolung plus SOC IMV

Invasive mechanical ventilation DEVICE

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.

Hemolung plus SOC IMV; SOC IMV

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Alung Technologies: lead

Study Sites (32)

UC Davis Medical Group

Sacramento, California, 95817, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

University of Florida - Health Shands

Gainesville, Florida, 32610, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

WellStar Kennestone Regional Medical Center

Marietta, Georgia, 30060, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Lexington VA Healthcare

Lexington, Kentucky, 40502, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

LSU Health Shreveport

Shreveport, Louisiana, 71103, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49504, United States

Location

Minneapolis Heart

Minneapolis, Minnesota, 55407, United States

Location

Rutgers-Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08902, United States

Location

Albany Medical Center

Albany, New York, 12208-3412, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

New York Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

UT Erlanger

Chattanooga, Tennessee, 37403, United States

Location

Memphis VA Medical Center

Memphis, Tennessee, 38104, United States

Location

UT McGovern Medical School Memorial Hermann

Houston, Texas, 77030, United States

Location

Baylor Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22903, United States

Location

Inova Health Care Services

Falls Church, Virginia, 22042, United States

Location

Related Publications (3)

• 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.

  PMID: 23460154 BACKGROUND

• Duggal 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.

  PMID: 38261630 DERIVED

• Stokes 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.

  PMID: 33854019 DERIVED

Study Officials

• Nicholas Hill, MD

  Tufts University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventional device and treatment, the study participants, care providers, and investigators will not be masked. However, an independent Clinical Endpoint Committee will be masked for adjudication of the primary endpoint and serious adverse events. An independent Data and Safety Monitoring Board will make study continuation recommendations based on the statistical analysis plan and the overall safety and efficacy endpoints without masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, randomized, controlled, two-arm, open-label, adaptive, two-strata, pivotal trial

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 21, 2017
• Study Start: February 18, 2018
• Primary Completion: August 10, 2022
• Study Completion: August 17, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

US (32)