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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT06615492
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing lung transplant surgery
Exclusion Criteria:
* Inability to provide consent for the study
* Retransplantation
* Multi-organ transplantation
* Contra-indication to standard heparin anticoagulation (e.g., heparin-induced thrombocytopenia)
* Lung transplant recipients where intraoperative cardiopulmonary support is mandatory:
* Severe pulmonary hypertension (PH):
1. Systolic pulmonary artery pressure (PAP) ≥ 80 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
2. Mean PAP ≥ 55 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
3. The ratio of mean pulmonary to systemic artery pressure of \> 0.66
* Moderate to severe right ventricular (RV) hypokinesis or dysfunction
* Left ventricular dysfunction: Defined as ejection fraction (LVEF) less than 45% on echocardiography, ventriculography, computed tomography (CT), or magnetic resonance imaging (MRI)
* Patients requiring concomitant cardiac surgery: For example, significant coronary artery disease (CAD) requiring surgical grafting
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06615492
Study Brief:
Protocol Section:
NCT06615492