Autologous Blood Patch for Primary Spontaneous Pneumothorax

NCT06088901 | Withdrawn

• 1 other identifier: 23030702
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Spontaneous Pneumothorax

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Prolonged Air Leak (>48 hours)

  30 days

• Procedural Pain score

  30 days

Other Outcomes (1)

• Incidence of Infectious Complications

  30 days

Study Arms (2)

Arm 1: First Occurrence

EXPERIMENTAL

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

Arm 2: Recurrence

EXPERIMENTAL

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

Interventions

Autologous Blood Patch PROCEDURE

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.

Arm 1: First Occurrence; Arm 2: Recurrence

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Known hematologic disorders Hemodynamic instability at the time of presentation

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Brian Gulack, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All patients presenting with first occurrence of a PSP who meet criteria for chest tube placement, between the ages of 13-18, will be offered inclusion in Arm 1. All patients presenting with recurrent PSP who meet criteria for blebectomy with a pleural procedure, between the ages of 13-18, will be offered inclusion in Arm 2.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)