Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06088901 |
| Other study ID # |
23030702 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2024 |
| Est. completion date |
May 2027 |
Study information
| Verified date |
May 2024 |
| Source |
Rush University Medical Center |
| Contact |
Brian Gulack, MD |
| Phone |
3129425500 |
| Email |
brian_gulack[@]rush.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
