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Autologous Blood Patch for Primary Spontaneous Pneumothorax

Primary Purpose

Primary Spontaneous Pneumothorax

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autologous Blood Patch
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Spontaneous Pneumothorax

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm 1: First Occurrence

    Arm 2: Recurrence

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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 us 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.

    Secondary Outcome Measures

    Incidence of Prolonged Air Leak (>48 hours)
    There is no standardized definition of prolonged air leak but our 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.
    Procedural Pain score
    Due to concerns that the algorithm may impact patient pain, we will gather data on postoperative pain scores used by nursing staff to evaluate need for additional pain medication.

    Full Information

    First Posted
    October 12, 2023
    Last Updated
    October 12, 2023
    Sponsor
    Rush University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06088901
    Brief Title
    Autologous Blood Patch for Primary Spontaneous Pneumothorax
    Official Title
    Utilization of Prophylactic Autologous Blood Patch Pleurodesis in the Treatment of Primary Spontaneous Pneumothorax
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rush University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    We 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. Our 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.6,7 We hypothesize that this benefit extends to the surgical management of PSP. Our 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Spontaneous Pneumothorax

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1: First Occurrence
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Arm 2: Recurrence
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Autologous Blood Patch
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Hospital Length of Stay
    Description
    Total hospital length of stay will allow a comprehensive evaluation of the efficacy of the intervention. As a continuous variable, this will give us 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.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Incidence of Prolonged Air Leak (>48 hours)
    Description
    There is no standardized definition of prolonged air leak but our 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.
    Time Frame
    30 days
    Title
    Procedural Pain score
    Description
    Due to concerns that the algorithm may impact patient pain, we will gather data on postoperative pain scores used by nursing staff to evaluate need for additional pain medication.
    Time Frame
    30 days
    Other Pre-specified Outcome Measures:
    Title
    Incidence of Infectious Complications
    Description
    Although not seen in the pediatric literature, adult literature has described a case of empyema after autologous blood patch. We will therefore keep track of any of these negative outcomes in this pilot study.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Brian Gulack, MD
    Phone
    3129425500
    Email
    brian_gulack@rush.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anna Alecci
    Phone
    3129421614
    Email
    anna_t_alecci@rush.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian Gulack, MD
    Organizational Affiliation
    Rush University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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