An interventional study of Autologous Blood Patch and Standard of Care (per Physician) in Lung Cancer, sponsored by Rush University Medical Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-10.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment
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
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
60-120ml of patient's blood will be drawn and inserted into patient's chest tube. A minimum of 60ml of blood is required, with the optimal amount of blood being 120ml.
Procedure: Autologous Blood Patch
Chest tube remains intact without blood patch.
Procedure: Standard of Care (per Physician)
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.
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.
Prolonged Air Leak >5 days
Definition of prolonged air leak: air leak present at 5 days or greater
Time frame: Within 30 Days
Hospital Length of Stay
Number of days patient was admitted inpatient
Time frame: Within 30 Days
Readmission within 30 days
Determination of whether the patient was readmitted after discharge within 30 days.
Time frame: Within 30 Days
In hospital mortality
Survival status while inpatient.
Time frame: Within 30 Days
30-day Mortality
Survival status within 30 days consent.
Time frame: Within 30 Days
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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