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Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial

NCT04954625 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Christopher Seder, MD · Rush University Medical Center

  • Sebastien Gilbert, MD · University of Ottawa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954625 on ClinicalTrials.gov