BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anakinra.
- Who it may be relevant to
- Registry conditions: Lung Transplant Recipient. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study will determine if primary graft dysfunction (which causes low blood oxygen levels and fluid or inflammation in the lungs) after lung transplant can be prevented through the use of the study drug (IL-1 receptor antagonist, Anakinra). In this study, lung transplant participants who are randomized to the treatment group will have the study drug injected into the solution that their donor lungs are kept in prior to transplant.
Detailed description
After being informed about the study and potential risks, all patients giving written consent who undergo a lung transplant will be randomized in a 1:1 ratio to either the treatment or control group. Patients randomized to the treatment group will have one dose of the study drug, Anakinra, injected into the perfusion solution that their donor lungs are kept in just prior to lung transplant. Both groups will receive standard lung transplant care after implantation.
Interventions
- Drug Anakinra
100 mg injection
Primary outcome measures
- Primary graft dysfunction after lung transplant [Time frame: 3 days post lung transplant]
Secondary outcome measures (4)
- Length of ICU stay post lung transplant, assessed up to one year post transplant [Time frame: Days post lung transplant up to 52 weeks]
- Length of hospital stay post lung transplant, assessed up to one year post transplant [Time frame: Days post lung transplant up to 52 weeks]
- Length of ventilator use post lung transplant, assessed up to one year post transplant [Time frame: Days post lung transplant up to 52 weeks]
- Survival after lung transplant [Time frame: 30 days, 90 days and one year post lung transplant]
Eligibility criteria
Inclusion criteria
- Age 18 years or older.
- Planning to undergo transplantation of the lung.
- Willing and able to read, understand, and be capable of giving informed consent.
- Use of ex vivo lung perfusion (EVLP) prior to lung transplant.
Exclusion criteria
- Previous or current use of IL-1R antagonist drug.
- Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating, such as highly sensitized patients who require additional immunosuppression, multiorgan transplant, and re- transplant.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Northwestern University — Chicago
Identifiers
NCT: NCT07410312 · STU00223759