Clinical trial · Interventional
Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial
NCT04954625CI-TRIAL-00096496enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Blood Patch | Procedure | — | UNRESOLVED |
| Standard of Care (per Physician) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Autologous Blood Patch
- description
- 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.
- interventionNames
- Procedure: Autologous Blood Patch
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care (Per physician)
- description
- Chest tube remains intact without blood patch.
- interventionNames
- Procedure: Standard of Care (per Physician)
Primary outcomes (5)
- measure
- Prolonged Air Leak >5 days
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (30)
- BACKGROUNDU.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
- BACKGROUNDStephan 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 11083673
- BACKGROUNDBrunelli 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 15063235
- BACKGROUNDIsowa 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 12062302
- BACKGROUNDLiang 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 22982031
- BACKGROUNDGilbert 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 27457828
- BACKGROUNDAttaar 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.