Autologous Blood Patch for Lung Cancer

Overseen By Abigail Goerge

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Pneumonectomy, Sleeve lobectomy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether an autologous blood patch (a technique using a small amount of the patient's own blood) can prevent air leaks after lung cancer surgery. The goal is to determine if this method can reduce prolonged air leaks, which may affect recovery. Participants will receive either the blood patch or standard care to compare outcomes. Individuals who have undergone certain types of lung surgery for suspected lung cancer and have an air leak on the third day after surgery might be suitable candidates. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that could enhance post-surgery recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the autologous blood patch is safe for patients undergoing lung cancer resection?

Research has shown that using an autologous blood patch (ABP) to treat prolonged air leaks (PALs) is generally safe. An ABP involves taking a small amount of a patient's own blood and injecting it into their chest tube to help seal the leak. This method has been used for many years and is considered safe and affordable.

Studies have found that patients who received an ABP experienced fewer complications compared to those who did not. In some studies, more than 89% of patients had positive results. These findings suggest that ABP is a well-tolerated treatment for PALs after lung surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Autologous Blood Patch for lung cancer because it uses the patient's own blood to potentially seal air leaks in the lungs. Unlike traditional treatments that might rely on surgery or synthetic materials, this method involves drawing 60-120ml of the patient's blood and inserting it into the chest tube, providing a natural and potentially less invasive solution. This approach could offer a more personalized treatment option, reducing the risk of rejection and complications associated with foreign substances.

What evidence suggests that this trial's treatments could be effective for preventing prolonged air leak after lung cancer resection?

In this trial, participants will receive either an autologous blood patch (ABP) or the standard of care. Research has shown that an ABP can effectively reduce long-lasting air leaks after lung surgery. One study found that ABP successfully stopped air leaks in over 89% of cases. Another study noted a significant drop in pneumothorax cases, a condition where a lung collapses, with the use of ABP. This treatment is often the first choice for managing air leaks in certain situations. Overall, ABP appears promising for helping patients recover faster and with fewer complications after lung surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Sebastien Gilbert, MD

Principal Investigator

University of Ottawa

Christopher W Seder, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who had lung cancer surgery and have an air leak on the third day after their operation. It's not for those who had more extensive surgeries like pneumonectomy, or women who are pregnant.

Inclusion Criteria

I had surgery to remove part of my lung for suspected 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

I have an air leak from my surgery site on the third day after surgery.

Exclusion Criteria

I am currently pregnant.

I have had surgery to remove a lung, part of a lung, chest wall, diaphragm, or had surgery on both sides of my chest.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous blood patch intervention on postoperative day 3 and possibly day 4

2 days

In-person visits on postoperative days 3 and 4

Follow-up

Participants are monitored for safety and effectiveness after treatment, including questionnaire completion

30 days

Follow-up in clinic or via telephone

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Blood Patch
• Standard of Care

Trial Overview The study tests if using a patient's own blood to create a patch (ABP) can prevent leaks in the lungs after cancer surgery. Patients will either get this new treatment or the usual care, and researchers will compare how well each works.

How Is the Trial Designed?

Group I: Autologous Blood Patch Experimental Treatment 1 Intervention

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.

Group II: Standard of Care (Per physician) Active Control 1 Intervention

Chest tube remains intact without blood patch.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

In a study involving 987 patients with advanced non-small-cell lung cancer (NSCLC), bevacizumab combined with platinum-based chemotherapy showed a median progression-free survival of 7.4 months and an overall response rate of 45.6%, confirming its effectiveness as a first-line treatment.

The safety profile of bevacizumab was consistent with previous studies, with 33.6% of patients experiencing grade ≥3 adverse drug reactions, primarily leukopenia, neutropenia, and hypertension, but no new safety concerns were identified, indicating it is well tolerated even after more than 20 treatment cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVAiLABLE NIS - AVASTIN® in lung cancer treatment in routine oncology practice in Germany. Zahn, MO., Linck, D., Losem, C., et al.[2020]

In a phase 3 trial involving 1501 patients with early-stage non-small-cell lung cancer (NSCLC), the addition of bevacizumab to standard adjuvant chemotherapy did not improve overall survival compared to chemotherapy alone, with a median follow-up of 50.3 months.

While bevacizumab was associated with higher rates of grade 3-5 toxicities, including hypertension and neutropenia, the overall survival rates were similar between the two treatment groups, indicating that bevacizumab should not be used as an adjuvant therapy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy with or without bevacizumab in patients with resected non-small-cell lung cancer (E1505): an open-label, multicentre, randomised, phase 3 trial. Wakelee, HA., Dahlberg, SE., Keller, SM., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11177476/

Efficacy of autologous blood patch injection for ... Our study indicated that the use of ABP was effective technique in reducing the pneumothorax and chest tube insertion rate after CT-PTLB.

2. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-01707-9

Autologous blood patch intraparenchymal injection reduces ... Conclusion deduced showed a noteworthy reduction in the overall incidence of pneumothorax (RR = 0.65; 95% CI 0.53–0.80; P = 0.00) and a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10115736/

The Efficacy and Safety of Autologous Blood Patch for ... Current evidence indicates that ABP may be considered a gold standard or first-line treatment for PAL caused by certain medical conditions, such ...

4. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(21)01005-5/fulltext

Efficacy of an Autologous Blood Patch for Prolonged Air Leak The majority of studies demonstrated a beneficial effect of the ABP, with a high rate of success of more than 89%. One randomized trial did not ...

5. jtd.amegroups.org jtd.amegroups.org/article/view/51568/html

Autologous blood patch pleurodesis for prolonged ... In 1987, Robinson et al. were the first to report an efficacy of 85% (21/25 patients) using ABPP for spontaneous pneumothorax, followed by Dumire et al.

6. mayo.edu mayo.edu/research/clinical-trials/cls-20572190

Prolonged Air Leak (PAL) Autologous Blood Patch ... The purpose of this study is to determine the safety and efficacy of autologous blood patch as a means to reduce the rate of prolonged air leak after lung ...