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:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT06824402
Eligibility Criteria:
Inclusion Criteria
* Male and female lung transplant recipients age \>18 at the time of informed consent
* Patients clinically meet indication for post-transplant lung biopsy or planned routine surveillance and have been scheduled for bronchoscopy with transbronchial biopsy.
* Be willing and able to sign the informed consent.
Exclusion Criteria
* Patients with known bleeding diathesis
* Platelet count \<50,000 per μL within 14 days of the biopsy procedure
* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)
* Inability or unwillingness to give informed consent or study procedures
* Pregnant or nursing females, or females who intend to become pregnant
* Females of child-bearing potential who decline a pregnancy test prior to enrollment
* If an investigator does not feel that this study is in the subject's best interest or would be a good fit for the study.
* International Normalized Ratio (INR) \>1.5
* Do Not Resuscitate (DNR) status
* Do Not Intubate (DNI) status
* Single lung transplant recipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06824402
Study Brief:
Protocol Section:
NCT06824402