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Brain DeathGOLDNCT03439995

Goal of Open Lung Ventilation in Donors

A study testing Open lung protective ventilation and Conventional ventilation in people with Brain Death and Organ Donation, run by Vanderbilt University Medical Center at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary goal of this study is to assess whether ventilation of deceased organ donors with an open lung protective ventilatory strategy will improve donor lung utilization rates and donor oxygenation compared to a conventional ventilatory strategy. Read more about this study

Who is it for?
Ages 13 years and older
What is being tested?
Open lung protective ventilation and Conventional ventilation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
4 sitesUnited States
Study dates
9 Jul 2018to 1 Jan 2021
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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Brain death
  • Authorization for research
  • ≥13 years of age

Who cannot join

  • Arterial/Inspired oxygen ratio (PaO2/FiO2) ≤ 150 mmHg
  • PaO2/FiO2 ≥ 400 mmHg
  • BMI > 40
  • Hepatitis B surface antigen positive
  • Hepatitis C positive
  • Failure to complete donation process
  • Hemodynamic instability

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • UCLA

    Los Angeles, California, 90095

  • Stanford University

    Palo Alto, California, 94305

  • University of California San Francisco

    San Francisco, California, 94143

  • Donor Network West

    San Ramon, California, 94583

Other trials in United States

About this study

The primary goal of this study is to assess whether ventilation of deceased organ donors with an open lung protective ventilatory strategy will improve donor lung utilization rates and donor oxygenation compared to a conventional ventilatory strategy.

Read the detailed description

Deceased organ donors are maintained on life support including mechanical ventilation during the time between brain death and organ procurement. The optimal mode of mechanical ventilation for deceased organ donors has not been definitively established. Since deceased organ donors may develop atelectasis leading to impaired oxygenation, an open lung protective ventilatory strategy with higher positive end expiratory pressure (PEEP), lower tidal volume and recruitment maneuvers has been hypothesized to be beneficial. Favorable outcomes were observed in a European clinical trial comparing open lung protective ventilation (OLPV) to a conventional ventilatory strategy in terms of donor oxygenation and lung utilization for transplantation (Mascia L et al, Journal of the American Medical Association 2010). However, donor management procedures in Europe are much shorter in duration compared to the US and it is not clear that these findings are generalizable to the US donor management environment.

The GOLD trial will test the effect of an OLPV strategy compared to conventional ventilation (CV) in the US donor management environment. This multi center trial will enroll 400 brain dead organ donors randomized into 1 of 2 treatment arms. After randomization, mechanical ventilation will be protocolized according to treatment arm with one arm receiving control ventilation (CV) utilizing standard Donor Network West (DNW) protocols and the other arm receiving the OLPV strategy with higher positive end expiratory pressure (PEEP) and lower tidal volume compared to CV. The primary outcomes is donor lung utilization for transplantation.

Being tested
Open lung protective ventilation, Conventional ventilation
Medical subject headings
Brain Death, Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open lung protective ventilationOther

    Higher PEEP, lower tidal volume mechanical ventilation

  • Conventional ventilationOther

    Lower PEEP, standard tidal volume mechanical ventilation

Study groups in NCT03439995
Study groupRoleWhat they receive
Open Lung Protective VentilationExperimentalVolume cycled assist control ventilation with tidal volume 8 cc/kg predicted body weight, PEEP 10 cm water (H2O), recruitment maneuvers every 8 hours and after any ventilator disconnect
Receives: Other: Open lung protective ventilation
Conventional VentilationActive comparatorVolume cycled assist control ventilation with tidal volume 10 cc/kg predicted body weight, PEEP 5 cm H2O, recruitment maneuvers after any ventilator disconnect
Receives: Other: Conventional ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Donor lung utilization rate

    Percent of donor lungs procured and transplanted into recipient

    Measured: during donor management period (usually 12-48 hours)

Secondary outcomes (6)

  1. Donor lung utilization in likely donors

    Percent of donor lungs used from donors with < 50 pack year smoking, age < 65, negative serologies, and no underlying chronic lung disease

    Measured: during donor management period (usually 12-48 hours)

  2. Donor oxygenation

    Change in donor arterial oxygen (PaO2) from enrollment to procurement

    Measured: during donor management period (usually 12-48 hours)

  3. Donor static compliance of the respiratory system

    Change in compliance of the respiratory system (in ml/cm H2O) from enrollment to procurement. Static compliance (Cstat) is calculated as Cstat = ΔV / Pplat - PEEP where V is the volume delivered by the ventilator, Pplat is the end-inspiratory plateau pressure and PEEP is the level of positive end expiratory pressure.

    Measured: during donor management period (usually 12-48 hours)

  4. Donor radiographic atelectasis scoring

    Change in chest radiograph atelectasis score from enrollment to procurement

    Measured: during donor management period (usually 12-48 hours)

  5. Recipient primary graft dysfunction

    International Society of Heart and Lung Transplantation grade 2 or 3 primary graft dysfunction in lung transplant recipient

    Measured: 72 hours after transplant

  6. Recipient mortality

    Lung transplant recipient death

    Measured: 30 days after transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2018
  2. Study start9 Jul 2018
  3. Primary completion1 Jan 2020
  4. Study completion1 Jan 2021

Why it stopped: Trial no longer feasible

Resources

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
Enrolled donors will be randomly assigned to two different modes of mechanical ventilation for the duration of donor management
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03439995
Sponsor's protocol ID
R01HL126176
Acronym
GOLD
Status last verified
May 2021
First submitted
14 Feb 2018
Last updated
6 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mascia L, Pasero D, Slutsky AS, Arguis MJ, Berardino M, Grasso S, Munari M, Boifava S, Cornara G, Della Corte F, Vivaldi N, Malacarne P, Del Gaudio P, Livigni S, Zavala E, Filippini C, Martin EL, Donadio PP, Mastromauro I, Ranieri VM. Effect of a lung protective strategy for organ donors on eligibility and availability of lungs for transplantation: a randomized controlled trial. JAMA. 2010 Dec 15;304(23):2620-7. doi: 10.1001/jama.2010.1796.

    PubMed 21156950

  • Ware LB, Koyama T, Shaver CM, Swain S, Nguyen J, Salehi A, Dhillon G, Wickersham N, Maheshwari J, Singer JP, Weigt SS, Kukreja J, Matthay MA. A randomized trial of open lung protective ventilation compared to conventional mechanical ventilation in deceased organ donors. J Heart Lung Transplant. 2025 Aug;44(8):1251-1259. doi: 10.1016/j.healun.2025.03.027. Epub 2025 Apr 3.

    PubMed 40187505

Questions about this trial

What is this clinical trial studying?

A study testing Open lung protective ventilation and Conventional ventilation in people with Brain Death and Organ Donation, run by Vanderbilt University Medical Center at 4 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 3 inclusion and 7 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 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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: Trial no longer feasible). 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?

Donor lung utilization rate (time frame: during donor management period (usually 12-48 hours)). 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 NCT03439995, which also lists 2 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 6 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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