NCT04954625

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
8mo left

Started Jul 2021

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jul 2021Dec 2026

First Submitted

Initial submission to the registry

June 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 10, 2025

Status Verified

October 1, 2025

Enrollment Period

5.5 years

First QC Date

June 28, 2021

Last Update Submit

October 8, 2025

Conditions

Lung Cancer

Keywords

SurgeryProlonged Air LeakAutologous Blood PatchLung

Outcome Measures

Primary Outcomes (5)

  • Prolonged Air Leak >5 days

    Definition of prolonged air leak: air leak present at 5 days or greater

    Within 30 Days

  • Hospital Length of Stay

    Number of days patient was admitted inpatient

    Within 30 Days

  • Readmission within 30 days

    Determination of whether the patient was readmitted after discharge within 30 days.

    Within 30 Days

  • In hospital mortality

    Survival status while inpatient.

    Within 30 Days

  • 30-day Mortality

    Survival status within 30 days consent.

    Within 30 Days

Study Arms (2)

Autologous Blood Patch

EXPERIMENTAL

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

Standard of Care (Per physician)

ACTIVE COMPARATOR

Chest tube remains intact without blood patch.

Procedure: Standard of Care (per Physician)

Interventions

Autologous Blood PatchPROCEDURE

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.

Autologous Blood Patch
Standard of Care (per Physician)PROCEDURE

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.

Standard of Care (Per physician)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who undergo pneumonectomy, sleeve lobectomy, chest wall or diaphragm resection, or bilateral procedures.
  • Age \< 18 years old
  • Women who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (30)

  • 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

    BACKGROUND

  • 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.

    PMID: 11083673BACKGROUND

  • 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.

    PMID: 15063235BACKGROUND

  • 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.

    PMID: 12062302BACKGROUND

  • 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.

    PMID: 22982031BACKGROUND

  • 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.

    PMID: 27457828BACKGROUND

  • 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.

    PMID: 27912898BACKGROUND

  • 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.

    PMID: 21489831BACKGROUND

  • 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.

    PMID: 20609776BACKGROUND

  • 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.

    PMID: 21871301BACKGROUND

  • 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.

    PMID: 15691692BACKGROUND

  • 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.

    PMID: 28089646BACKGROUND

  • 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.

    PMID: 15691691BACKGROUND

  • 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.

    PMID: 20172150BACKGROUND

  • 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.

    PMID: 24624291BACKGROUND

  • 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.

    PMID: 15797045BACKGROUND

  • 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.

    PMID: 22943333BACKGROUND

  • 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.

    PMID: 31323209BACKGROUND

  • 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.

    PMID: 27865325BACKGROUND

  • 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.

    PMID: 10921721BACKGROUND

  • 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.

    PMID: 15519179BACKGROUND

  • 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.

    PMID: 19556743BACKGROUND

  • 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.

    PMID: 20013622BACKGROUND

  • 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.

    PMID: 16928534BACKGROUND

  • 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.

    PMID: 20628018BACKGROUND

  • 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.

    PMID: 22498731BACKGROUND

  • 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.

    PMID: 19881163BACKGROUND

  • 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.

    PMID: 9636962BACKGROUND

  • Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.

    PMID: 33532112BACKGROUND

  • 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.

    PMID: 21714641BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Christopher Seder, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

  • Sebastien Gilbert, MD

    University of Ottawa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 8, 2021

Study Start

July 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 10, 2025

Record last verified: 2025-10

Locations

US(1)