Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT03388008
Eligibility Criteria:
Inclusion Criteria:
* Provided written informed consent for study participation
* Underwent single or bilateral lung transplantation
* Negative urine pregnancy test for women of child bearing potential and willingness to use highly-effective contraception
Exclusion Criteria:
* Requiring invasive mechanical ventilation immediately before transplantation
* Requiring extracorporeal life support (ECLS) (i.e., ECMO) immediately before transplantation
* Received treatment to deplete HLA antibodies before transplantation to improve the possibility of transplantation
* Having DSA immediately before transplantation (i.e., positive virtual crossmatch)
* Listed for multi-organ transplant (e.g., heart-lung, liver-lung, kidney-lung)
* Pregnant or breast-feeding
* Active infection with Hepatitis B or C virus
* Active infection with human immunodeficiency virus (HIV)
* Chronic infection with Burkholderia cepacia complex before transplantation
* Epstein Barr Virus (EBV) seronegative status
* Participation in another interventional clinical trial
* Allograft dysfunction requiring ECMO support after transplantation
* Delayed chest closure after transplantation
* Severe coagulopathy and significant bleeding in the opinion of the PI
* Any condition that in the opinion of the site PI introduces undue risk by participating in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03388008
Study Brief:
Protocol Section:
NCT03388008