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:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT00402532
Eligibility Criteria:
Inclusion Criteria:
* Recipient of Single or Bilateral Lung Transplantation
* Informed consent
* Recipients who are able to receive Everolimus at week 3 after Lung Transplantation
* women of childbearing potential must have a negative pregnancy test within 48 hours of enrolment
* women of childbearing potential must use appropriate contraceptive method at enrolment, during the study and up to 8 weeks after the end of the study
* donor must not have relevant pulmonary diseases
* donor must have oxygen partial pressure higher than 300 mmHg at FiO 1.0 and positive end-expiratory pressure of 5 cm H2O.
Exclusion Criteria:
* systemic infection of the donor
* donor: signs or symptoms of aspiration
* donor: severe pulmonary injury or contusion
* donor: malignant neoplasm of the lung
* donor: HIV positive
* recipients who receive immunosuppressive agents not used in this protocol
* recipients who participated within 30 days before study start or are currently participating in another investigational drug trial
* HIV positive recipient
* systemic infection of the recipient
* recipients of combined/ multiple transplantations
* pregnancy of the recipient
* recipients with signs/ Symptoms of impaired wound healing of the pulmonary anastomoses
* recipients who are still on artificial respiration or who are not able to swallow tablets at week 3 after transplantation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00402532
Study Brief:
Protocol Section:
NCT00402532