Health TrialsbyHealthPanel

BRIDGE - Blocking Receptor of IL-1β for Donor Graft Edema Reduction

ConditionLung Transplant Recipient
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anakinra

    Drug

    100 mg injection

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Treatment group: Anakinra during EVLPExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Primary graft dysfunction after lung transplant

Occurrence of primary graft dysfunction after lung transplant on post-operative day 3, measured by arterial blood gas blood tests and chest X-rays.

Time frame
3 days post lung transplant

Secondary outcomes

1

Length of ICU stay post lung transplant, assessed up to one year post transplant

Length of intensive care unit stay post lung transplant

Time frame
Days post lung transplant up to 52 weeks
2

Length of hospital stay post lung transplant, assessed up to one year post transplant

Length of hospital stay post lung transplant

Time frame
Days post lung transplant up to 52 weeks
3

Length of ventilator use post lung transplant, assessed up to one year post transplant

Length of ventilator use post lung transplant

Time frame
Days post lung transplant up to 52 weeks
4

Survival after lung transplant

30 days, 90 days, and one year survival status after lung transplant

Time frame
30 days, 90 days and one year post lung transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: