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Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
Trial Status: enrolling by invitation
A postoperative autologous blood patch (ABP) intervention trial for patients who
underwent lung resection for cancer to examine its effectiveness in preventing a
prolonged air leak.
AIM 1: To determine the safety and efficacy of autologous blood patch (ABP) as a means to
reduce the rate of prolonged air leak (PAL) after lung cancer resection
AIM 2: To prospectively examine variation in morbidity and quality of life between
patients with and without a PAL
Inclusion Criteria
Patients who underwent elective wedge resection, segmentectomy, lobectomy, or bilobectomy for suspected non-small cell lung cancer
Patients that 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
Patients who have an air leak on the morning of postoperative Day 3
Age ≥18 years old
Exclusion Criteria
Patients who undergo pneumonectomy, sleeve lobectomy, chest wall or diaphragm resection, or bilateral procedures.
Age < 18 years old
Women who are pregnant
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04954625.
Locations matching your search criteria
United States
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
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
