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.
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
- Conditions the study is for
- Brain Death, Organ Donation, Organ Transplant Failure or Rejection
- 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
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 group | Role | What they receive |
|---|---|---|
| Open Lung Protective Ventilation | Experimental | Volume 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 Ventilation | Active comparator | Volume 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.
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)
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)
Donor oxygenation
Change in donor arterial oxygen (PaO2) from enrollment to procurement
Measured: during donor management period (usually 12-48 hours)
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)
Donor radiographic atelectasis scoring
Change in chest radiograph atelectasis score from enrollment to procurement
Measured: during donor management period (usually 12-48 hours)
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
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.
- First posted20 Feb 2018
- Study start9 Jul 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2021
Why it stopped: Trial no longer feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Los Angeles, Stanford University, Donor Network West
- Responsible party
- Principal investigator, Lorraine B. Ware, Vanderbilt University Medical Center
- Investigators
- Lorraine B Ware, MD, Principal investigator, Vanderbilt University Medical Center
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 21156950Ware 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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal of Open Lung Ventilation in Donors
- ClinicalTrials.gov ID
- NCT03439995
- Acronym / sponsor ID
- GOLD / R01HL126176
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial no longer feasible
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Los Angeles, Stanford University, Donor Network West
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 20 Feb 2018 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Enrolled donors will be randomly assigned to two different modes of mechanical ventilation for the duration of donor management
| Arm | Type | Receives |
|---|---|---|
| Open Lung Protective Ventilation | Experimental | Other: Open lung protective ventilationVolume 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 |
| Conventional Ventilation | Active comparator | Other: Conventional ventilationVolume cycled assist control ventilation with tidal volume 10 cc/kg predicted body weight, PEEP 5 cm H2O, recruitment maneuvers after any ventilator disconnect |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Brain death
- Authorization for research
- ≥13 years of age
Key exclusion criteria (7 listed)
- Arterial/Inspired oxygen ratio (PaO2/FiO2) ≤ 150 mmHg
- PaO2/FiO2 ≥ 400 mmHg
- BMI > 40
- Hepatitis B surface antigen positive
- Hepatitis C positive
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 |
|---|---|---|
| Open lung protective ventilationHigher PEEP, lower tidal volume mechanical ventilation | Other | Open Lung Protective Ventilation |
| Conventional ventilationLower PEEP, standard tidal volume mechanical ventilation | Other | Conventional Ventilation |
Primary outcome
Donor lung utilization rate
Time frame: during donor management period (usually 12-48 hours)
Percent of donor lungs procured and transplanted into recipient
6 secondary outcomes
Donor lung utilization in likely donors
Time frame: during donor management period (usually 12-48 hours)
Donor oxygenation
Time frame: during donor management period (usually 12-48 hours)
Donor static compliance of the respiratory system
Time frame: during donor management period (usually 12-48 hours)
Donor radiographic atelectasis scoring
Time frame: during donor management period (usually 12-48 hours)
Recipient primary graft dysfunction
Time frame: 72 hours after transplant
Recipient mortality
Time frame: 30 days after transplant
Results and safety
The study was stopped early (reason given: Trial no longer feasible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 21156950Mascia 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.
- Derived from this study: PubMed 40187505Ware 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.
- Individual participant dataSharing planned: No
Related trials for Brain Death
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Not yet recruitingObservational study
Brain-based Prediction of the Dying Duration in Humans After Withdrawal of Life Sustaining Therapies to Inform Donation After Circulatory Death
Organ Donation After Circulatory Death
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingPhase 2
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
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.
Lorraine B Ware, MD principal investigator
Vanderbilt University Medical Center
4 sites in 1 country: see every site and its status.
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.