Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial

Lung Cancer Clinical Trial

Official title:

Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04954625
• Other study ID #: 19072606
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: August 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.
• 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

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (30)

ACS. American Cancer Society. Cancer Facts & Figures 2018. Available at https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-andfigures/2018/cancer-facts-and-figures-2018.pdf.

Athanassiadi K, Bagaev E, Haverich A. Autologous blood pleurodesis for persistent air leak. Thorac Cardiovasc Surg. 2009 Dec;57(8):476-9. doi: 10.1055/s-0029-1185913. — View Citation

Attaar A, Winger DG, Luketich JD, Schuchert MJ, Sarkaria IS, Christie NA, Nason KS. A clinical prediction model for prolonged air leak after pulmonary resection. J Thorac Cardiovasc Surg. 2017 Mar;153(3):690-699.e2. doi: 10.1016/j.jtcvs.2016.10.003. Epub 2016 Oct 14. — View Citation

Brunelli A, Monteverde M, Borri A, Salati M, Marasco RD, Fianchini A. Predictors of prolonged air leak after pulmonary lobectomy. Ann Thorac Surg. 2004 Apr;77(4):1205-10; discussion 1210. doi: 10.1016/j.athoracsur.2003.10.082. — View Citation

Brunelli A, Varela G, Refai M, Jimenez MF, Pompili C, Sabbatini A, Aranda JL. A scoring system to predict the risk of prolonged air leak after lobectomy. Ann Thorac Surg. 2010 Jul;90(1):204-9. doi: 10.1016/j.athoracsur.2010.02.054. — View Citation

Cagirici U, Sahin B, Cakan A, Kayabas H, Buduneli T. Autologous blood patch pleurodesis in spontaneous pneumothorax with persistent air leak. Scand Cardiovasc J. 1998;32(2):75-8. doi: 10.1080/14017439850140210. — View Citation

Chambers A, Routledge T, Bille A, Scarci M. Is blood pleurodesis effective for determining the cessation of persistent air leak? Interact Cardiovasc Thorac Surg. 2010 Oct;11(4):468-72. doi: 10.1510/icvts.2010.234559. Epub 2010 Jul 13. — View Citation

Cobanoglu U, Melek M, Edirne Y. Autologous blood pleurodesis: A good choice in patients with persistent air leak. Ann Thorac Med. 2009 Oct;4(4):182-6. doi: 10.4103/1817-1737.56011. — View Citation

Elsayed H, McShane J, Shackcloth M. Air leaks following pulmonary resection for lung cancer: is it a patient or surgeon related problem? Ann R Coll Surg Engl. 2012 Sep;94(6):422-7. doi: 10.1308/003588412X13171221592258. — View Citation

Gilbert S, Maghera S, Seely AJ, Maziak DE, Shamji FM, Sundaresan SR, Villeneuve PJ. Identifying Patients at Higher Risk of Prolonged Air Leak After Lung Resection. Ann Thorac Surg. 2016 Nov;102(5):1674-1679. doi: 10.1016/j.athoracsur.2016.05.035. Epub 2016 Jul 22. — View Citation

Isowa N, Hasegawa S, Bando T, Wada H. Preoperative risk factors for prolonged air leak following lobectomy or segmentectomy for primary lung cancer. Eur J Cardiothorac Surg. 2002 May;21(5):951. doi: 10.1016/s1010-7940(02)00076-3. No abstract available. — View Citation

Lang-Lazdunski L, Coonar AS. A prospective study of autologous 'blood patch' pleurodesis for persistent air leak after pulmonary resection. Eur J Cardiothorac Surg. 2004 Nov;26(5):897-900. doi: 10.1016/j.ejcts.2004.07.034. — View Citation

Lee L, Hanley SC, Robineau C, Sirois C, Mulder DS, Ferri LE. Estimating the risk of prolonged air leak after pulmonary resection using a simple scoring system. J Am Coll Surg. 2011 Jun;212(6):1027-32. doi: 10.1016/j.jamcollsurg.2011.03.010. Epub 2011 Apr 13. — View Citation

Liang S, Ivanovic J, Gilbert S, Maziak DE, Shamji FM, Sundaresan RS, Seely AJE. Quantifying the incidence and impact of postoperative prolonged alveolar air leak after pulmonary resection. J Thorac Cardiovasc Surg. 2013 Apr;145(4):948-954. doi: 10.1016/j.jtcvs.2012.08.044. Epub 2012 Sep 13. — View Citation

Liberman M, Muzikansky A, Wright CD, Wain JC, Donahue DM, Allan JS, Gaissert HA, Morse CR, Mathisen DJ, Lanuti M. Incidence and risk factors of persistent air leak after major pulmonary resection and use of chemical pleurodesis. Ann Thorac Surg. 2010 Mar;89(3):891-7; discussion 897-8. doi: 10.1016/j.athoracsur.2009.12.012. — View Citation

Manley K, Coonar A, Wells F, Scarci M. Blood patch for persistent air leak: a review of the current literature. Curr Opin Pulm Med. 2012 Jul;18(4):333-8. doi: 10.1097/MCP.0b013e32835358ca. — View Citation

Mueller MR, Marzluf BA. The anticipation and management of air leaks and residual spaces post lung resection. J Thorac Dis. 2014 Mar;6(3):271-84. doi: 10.3978/j.issn.2072-1439.2013.11.29. — View Citation

National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. — View Citation

Okereke I, Murthy SC, Alster JM, Blackstone EH, Rice TW. Characterization and importance of air leak after lobectomy. Ann Thorac Surg. 2005 Apr;79(4):1167-73. doi: 10.1016/j.athoracsur.2004.08.069. — View Citation

Oliveira FH, Cataneo DC, Ruiz RL Jr, Cataneo AJ. Persistent pleuropulmonary air leak treated with autologous blood: results from a university hospital and review of literature. Respiration. 2010;79(4):302-6. doi: 10.1159/000226277. Epub 2009 Jun 24. — View Citation

Pompili C, Falcoz PE, Salati M, Szanto Z, Brunelli A. A risk score to predict the incidence of prolonged air leak after video-assisted thoracoscopic lobectomy: An analysis from the European Society of Thoracic Surgeons database. J Thorac Cardiovasc Surg. 2017 Apr;153(4):957-965. doi: 10.1016/j.jtcvs.2016.11.064. Epub 2016 Dec 22. — View Citation

Rivas de Andres JJ, Blanco S, de la Torre M. Postsurgical pleurodesis with autologous blood in patients with persistent air leak. Ann Thorac Surg. 2000 Jul;70(1):270-2. doi: 10.1016/s0003-4975(00)01360-6. — View Citation

Rivera C, Bernard A, Falcoz PE, Thomas P, Schmidt A, Benard S, Vicaut E, Dahan M. Characterization and prediction of prolonged air leak after pulmonary resection: a nationwide study setting up the index of prolonged air leak. Ann Thorac Surg. 2011 Sep;92(3):1062-8; discussion 1068. doi: 10.1016/j.athoracsur.2011.04.033. — View Citation

Rocco G, Brunelli A, Rocco R. Suction or Nonsuction: How to Manage a Chest Tube After Pulmonary Resection. Thorac Surg Clin. 2017 Feb;27(1):35-40. doi: 10.1016/j.thorsurg.2016.08.006. — View Citation

Seder CW, Basu S, Ramsay T, Rocco G, Blackmon S, Liptay MJ, Gilbert S. A Prolonged Air Leak Score for Lung Cancer Resection: An Analysis of The Society of Thoracic Surgeons General Thoracic Surgery Database. Ann Thorac Surg. 2019 Nov;108(5):1478-1483. doi: 10.1016/j.athoracsur.2019.05.069. Epub 2019 Jul 16. — View Citation

Shackcloth MJ, Poullis M, Jackson M, Soorae A, Page RD. Intrapleural instillation of autologous blood in the treatment of prolonged air leak after lobectomy: a prospective randomized controlled trial. Ann Thorac Surg. 2006 Sep;82(3):1052-6. doi: 10.1016/j.athoracsur.2006.04.015. — View Citation

Stephan F, Boucheseiche S, Hollande J, Flahault A, Cheffi A, Bazelly B, Bonnet F. Pulmonary complications following lung resection: a comprehensive analysis of incidence and possible risk factors. Chest. 2000 Nov;118(5):1263-70. doi: 10.1378/chest.118.5.1263. — View Citation

Stolz AJ, Schutzner J, Lischke R, Simonek J, Pafko P. Predictors of prolonged air leak following pulmonary lobectomy. Eur J Cardiothorac Surg. 2005 Feb;27(2):334-6. doi: 10.1016/j.ejcts.2004.11.004. — View Citation

U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999-2013 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2017. Available at: www.cdc.gov/uscs

Varela G, Jimenez MF, Novoa N, Aranda JL. Estimating hospital costs attributable to prolonged air leak in pulmonary lobectomy. Eur J Cardiothorac Surg. 2005 Feb;27(2):329-33. doi: 10.1016/j.ejcts.2004.11.005. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged Air Leak >5 days		Within 30 Days
Primary	Hospital Length of Stay		Within 30 Days
Primary	Readmission within 30 days		Within 30 Days
Primary	In hospital mortality		Within 30 Days
Primary	30-day Mortality		Within 30 Days