Clinical trial NCT04954625: Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
Official title: Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lung Cancer
Keywords: Surgery
Prolonged Air Leak
Autologous Blood Patch
Lung
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prolonged Air Leak >5 days
timeFrame: Within 30 Days
measure: Hospital Length of Stay
timeFrame: Within 30 Days
measure: Readmission within 30 days
timeFrame: Within 30 Days
measure: In hospital mortality
timeFrame: Within 30 Days
measure: 30-day Mortality
timeFrame: Within 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Christopher Seder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Sebastien Gilbert, MD
role: STUDY_DIRECTOR
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