Clinical Trial Title
Prolonged Air Leak (PAL) Autologous Blood Patch Multi-site Intervention TrialNational Clinical Trial Number:
NCT04954625Contact Information
Clinical Trial Protocol Description:
The plan for this trial is to establish the safety and efficacy of autologous blood patches as a means of reducing PAL following lung cancer resection. Patients with an air leak on the morning of postoperative Day 3 after elective lung resection for cancer will be randomized to ABP on postoperative Day 3 and Day 4 (if an air leak remains present), or standard care (n=60 per arm).
Subjects will be consented on postoperative Day 3, with autologous blood patch intervention occurring on Day 3 or Day 4. If subjects are randomized to the ABP arm of the trial, they will receive up to 120 ml of autologous blood sterilely drawn from a peripheral vein and immediately
instilled into the chest tube.
Subjects will then follow up either in clinic or via telephone to answer a quality of life questionnaire. Follow up occurs at 30 days (+/-5 days) postoperatively.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have undergone elective wedge resection, segmentectomy, lobectomy, or bilobectomy for suspected non-small cell lung cancer.
- Have reviewed and signed the Informed Consent Form, had an opportunity to ask questions, and consent to have their de-identified data included in the study.
- Have an air leak on the morning of postoperative Day 3.
You will be excluded from the study if any of the following criteria apply to you:
- Have undergone pneumonectomy, sleeve lobectomy, chest wall or diaphragm resection, or bilateral procedures.
- Are ≤ 18 years of age.
- Are pregnant or of childbearing potential.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.