Autologous Blood Patch for Primary Spontaneous Pneumothorax

Utilization of Prophylactic Autologous Blood Patch Pleurodesis in the Treatment of Primary Spontaneous Pneumothorax

The purpose of this study is to show that treatment with prophylactic autologous blood patch (ABP) after management of primary spontaneous pneumothorax (PSP) is feasible, reduces the incidence of prolonged air leaks, and reduces hospital length of stay. An ABP is a medical procedure that uses one's own blood in order to close one or many holes identified in the lungs. The blood modulates the pressure of the lungs and forms a clot, sealing the leak. Primary spontaneous pneumothorax is an abnormal collection of air in the pleural space between the lung and the chest wall.

Study Overview

• Status: Withdrawn
• Conditions: Primary Spontaneous Pneumothorax
• Intervention / Treatment: Procedure: Autologous Blood Patch

Detailed Description

The investigators will employ a novel treatment algorithm using a previously described technique to determine its feasibility and efficacy. This study will provide necessary quantitative and qualitative data to plan and obtain additional investigator-initiated funding to perform future comparative studies.

ARM 1 Purpose and Goals: Management of PSP at the initial presentation traditionally involves pleural drainage (although some opt for observation in mild cases). Unfortunately, prolonged pulmonary air leaks and recurrence are common, making PSP more consistent with a chronic disease than an acute process. While ABP has traditionally been used in instances of prolonged air leaks after chest tube placement, there is data from other patient populations that routine use at the time of the index procedure may reduce the incidence of prolonged air leaks and consequently patient morbidity and associated costs. The investigators' goal is to demonstrate the feasibility and efficacy of this technique.

Procedures: All patients who meet criteria and consent to involvement will be treated per institutional protocols with a tube thoracostomy. Chest tube size will be determined by the physician of record. Once the chest tube is placed, it will be placed to suction for a minimum of two minutes to allow for lung re-expansion while 2 ml/kg of whole blood (max 100 ml) is obtained via venipuncture (preferably a previously established intravenous catheter). This blood will then be injected via the chest tube which will then be clamped for 180 minutes, before being returned to suction. During this period of clamping, the patient will be rotated from side to side intermittently to help the blood move around the extrapleural space. The remainder of the management will be left to the discretion of the primary physician. The PSP procedure is considered standard of care.

ARM 2 Purpose and Goals: In adolescents who present with recurrent PSP, a resection of the most likely offending bleb as well as a pleural procedure to prevent recurrence is often indicated. Following surgical treatment, patients are hospitalized with a chest tube to manage any persistent air leaks. While the use of an ABP has most commonly been relegated to patients who have persistent air leaks beyond 5 days, previous data has demonstrated benefits of prophylactic ABPs in other pulmonary procedures. The investigators hypothesize that this benefit extends to the surgical management of PSP. The investigators' goal is to demonstrate the feasibility and efficacy of this technique when used prophylactically, in order to provide data for designing a multicenter prospective clinical trial.

Procedures: All patients who meet criteria and provide informed consent will be treated per institutional protocols with a thoracoscopic blebectomy and mechanical pleurodesis or pleurectomy. At the conclusion of the procedure, 2 ml/kg of whole blood (max 100 ml) obtained via venipuncture will be injected into the pleural space. The chest tube will be left clamped for 180 minutes post-procedure and then placed back to suction. During this period of clamping, the patient will be rotated from side to side intermittently to help the blood move around the extrapleural space. The remainder of the post-operative management will be left to the discretion of the primary physician. The PSP procedure is considered standard of care.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with primary spontaneous pneumothorax (first occurrence) and meets criteria for chest tube placement or Diagnosed with recurrent primary spontaneous pneumothorax (recurrence) and meets criteria for blebectomy with a pleural procedure
• Between the ages of 13-18

Exclusion Criteria:

Known hematologic disorders Hemodynamic instability at the time of presentation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: First Occurrence; All patients who meet criteria and consent to involvement will be treated per institutional protocols with a tube thoracostomy. Chest tube size will be determined by the physician of record. Once the chest tube is placed, it will be placed to suction for a minimum of two minutes to allow for lung re-expansion while 2 ml/kg of whole blood (max 100 ml) is obtained via venipuncture (preferably a previously established intravenous catheter). This blood will then be injected via the chest tube which will then be clamped for 180 minutes, before being returned to suction. During this period of clamping, the patient will be rotated from side to side intermittently to help the blood move around the extrapleural space.	Procedure: Autologous Blood Patch; 2 ml/kg of whole blood (max 100 ml) is obtained via venipuncture. This blood is then injected via the chest tube which will then be clamped for 180 minutes, before being returned to suction. During this period of clamping, the patient will be rotated from side to side intermittently to help the blood move around the extrapleural space.
Experimental: Arm 2: Recurrence; All patients who meet criteria and provide informed consent will be treated per institutional protocols with a thoracoscopic blebectomy and mechanical pleurodesis or pleurectomy. At the conclusion of the procedure, 2 ml/kg of whole blood (max 100 ml) obtained via venipuncture will be injected into the pleural space. The chest tube will be left clamped for 180 minutes post-procedure and then placed back to suction. During this period of clamping, the patient will be rotated from side to side intermittently to help the blood move around the extrapleural space.	Procedure: Autologous Blood Patch; 2 ml/kg of whole blood (max 100 ml) is obtained via venipuncture. This blood is then injected via the chest tube which will then be clamped for 180 minutes, before being returned to suction. During this period of clamping, the patient will be rotated from side to side intermittently to help the blood move around the extrapleural space.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Total hospital length of stay will allow a comprehensive evaluation of the efficacy of the intervention. As a continuous variable, this will give the investigators the most power to compare to historical controls. This will take into account not only changes in postoperative air leak but also additional effects from the research intervention.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Prolonged Air Leak (>48 hours)	There is no standardized definition of prolonged air leak but the investigators' previous analyses have focused on 48 hours as a cut-off. Around 50% of adolescents treated for primary spontaneous pneumothorax suffer from this complication leading to prolonged hospital stays and increased hospital costs, as well as impacting patient mental health.	30 days
Procedural Pain score	Due to concerns that the algorithm may impact patient pain, the investigators will gather data on postoperative pain scores used by nursing staff to evaluate need for additional pain medication. Nursing staff use a Numerical Rating Scale where the minimum value is 1 and the maximum value is 10, with 10 being the worst pain.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Infectious Complications	Although not seen in the pediatric literature, adult literature has described a case of empyema after autologous blood patch. The investigators will therefore keep track of any of these negative outcomes in this pilot study.	30 days

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Brian Gulack, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: 23030702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No