The plan for this trial is to establish the safety and efficacy of ABP 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). This will be a multi-institutional randomized, controlled trial open for
enrollment at centers in the United States and Canada. The study methods and design are
compliant with the Consolidated Standards of Reporting Trials (CONSORT).
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 60-100 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 the
questionnaire. If the subject is being seen in person, they will be handed a
questionnaire form to complete. This form will be kept and stored as source
documentation. If the patient is answering the questionnaire via telephone, the study
team personnel will record their answers on the questionnaire form, indicating it was
completed by the subject but recorded by study team personnel. A telephone encounter note
will be recorded and stored as source with the completed questionnaire. Follow up occurs
at 30 days (+/-5 days) postoperatively.
