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ENROLLING BY INVITATION
NCT04954625
NA

Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial

Sponsor: Rush University Medical Center

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-07-01

Completion Date

2026-12-31

Last Updated

2025-10-10

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Autologous Blood Patch

All patients will be assessed on the morning of postoperative Day 3 and 4 for the presence of an air leak. If an air leak is present, 60-100 ml of autologous blood will be drawn from a peripheral vein and immediately instilled into the chest tube. The individual who draws blood is that the discretion of the site principal investigator. The tubing will be elevated over an IV pole while the patient remains in bed, moving position every 15 minutes for 1 hour to distribute the blood throughout the pleural cavity. The tubing support will then be removed, allowing the chest tube to drain. After ABP intervention, the chest tube will remain to water seal, as long as the patient tolerates it.

PROCEDURE

Standard of Care (per Physician)

Patients randomized to Standard of Care will be treated as their surgeon would as routine. This may mean postoperative observation, of another type of intervention.

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States