A Phase 4 interventional study of tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) and Medical Thoracoscopy in Pleural Infection, Empyema and Pleural Diseases, sponsored by Tulane University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Tulane University · Phase 4, Interventional, and Treatment
The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion (CPPE) in adults.
Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies.
Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy
Methods: Investigators will conduct a prospective randomized clinical trial. Plan is to enroll total of 32 patients and randomize those patients to either Medical Thoracoscopy group or Fibrinolytic Therapy group.
Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting
Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection
Subjects >18 years old with:
Evidence of empyema or complex parapneumonic effusion
Exclusion Criteria:
Age \<18 years Pregnancy Inability to give informed written consent Previous thoracic surgery or thrombolytic therapy for pleural infection Medical thoracoscopy cannot be performed within 48 hours Hemodynamic instability or severe hypoxemia Non corrected coagulopathy Homogeneously echogenic effusion on pleural ultrasonography
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
Drug: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Procedure: Medical Thoracoscopy
Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
Medical thoracoscopy will be performed as per standard protocols.
Also known as: Pleuroscopy
Duration of Hospital Stay After Intervention
duration of hospital stay in days from time of procedure to discharge from hospital.
Time frame: 12 week follow up period
Total Length of Hospital Stay
Total days spent in the hospital
Time frame: 12 week follow up period
Number of Participants Necessitating Intervention After the Assigned Treatment
1. Need for surgical intervention (VATS, Open Thoracotomy) in any arm 2. Need for additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to treatment failure 3. Need of additional chest tube or additional fibrinolytic doses in the fibrinolytic therapy arm due to treatment failure
Time frame: 12 week follow up period
Adverse Events
any Adverse events (pain, bleeding)
Time frame: 12 week follow up period
In Hospital and 30-day Mortality
Death of a patient while being hospitalized or up to 30 days after
Time frame: 30 days
| Milestone | Fibrinolytic Therapy Group | Medical Thoracoscopy Group |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 16 |
| Not completed | 0 | 0 |
duration of hospital stay in days from time of procedure to discharge from hospital.
| days | Fibrinolytic Therapy Group | Medical Thoracoscopy Group |
|---|---|---|
| Duration of Hospital Stay After Intervention | 4 (4 to 5.5) | 2 (2 to 5) |
Total days spent in the hospital
| days | Fibrinolytic Therapy Group | Medical Thoracoscopy Group |
|---|---|---|
| Total Length of Hospital Stay | 6 (5 to 8.5) | 3.5 (2 to 10) |
1. Need for surgical intervention (VATS, Open Thoracotomy) in any arm 2. Need for additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to treatment failure 3. Need of additional chest tube or additional fibrinolytic doses in the fibrinolytic therapy arm due to treatment failure
| Participants | Fibrinolytic Therapy Group | Medical Thoracoscopy Group |
|---|---|---|
| Number of Participants Necessitating Intervention After the Assigned Treatment | 3 | 4 |
any Adverse events (pain, bleeding)
| Participants | Fibrinolytic Therapy Group | Medical Thoracoscopy Group |
|---|---|---|
| Adverse Events | 1 | 1 |
Death of a patient while being hospitalized or up to 30 days after
| Participants | Fibrinolytic Therapy Group | Medical Thoracoscopy Group |
|---|---|---|
| In Hospital and 30-day Mortality | 0 | 1 |
Collected over The perioperative period until hospital discharge, an average of 4 weeks per participant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fibrinolytic Therapy Group | 0/16 (0%) | 0/16 (0%) | 1/16 (6.3%) |
| Medical Thoracoscopy Group | 1/16 (6.3%) | 0/16 (0%) | 1/16 (6.3%) |
| Event | Fibrinolytic Therapy Group | Medical Thoracoscopy Group |
|---|---|---|
| RespiratoryRespiratory, thoracic and mediastinal disorders | 1/16 | 1/16 |
| Age, Continuous(years) | Fibrinolytic Therapy Group | Medical Thoracoscopy Group | Total |
|---|---|---|---|
| Median | 58 (49 to 65) | 65 (62.5 to 72.5) | 64 (54.5 to 69.75) |
| Sex: Female, Male(Participants) | Fibrinolytic Therapy Group | Medical Thoracoscopy Group | Total |
|---|---|---|---|
| Female | 6 | 2 | 8 |
| Male | 10 | 14 | 24 |
| Race and Ethnicity Not Collected(Participants) | Fibrinolytic Therapy Group | Medical Thoracoscopy Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Fibrinolytic Therapy Group | Medical Thoracoscopy Group | Total |
|---|---|---|---|
| United States | 16 | 16 | 32 |
| Ultrasonographic estimated pleural effusion volume,Moderate(Participants) | Fibrinolytic Therapy Group | Medical Thoracoscopy Group | Total |
|---|---|---|---|
| Count of participants | 13 | 13 | 26 |
| Number of subjects with community acquired pleural infection(Participants) | Fibrinolytic Therapy Group | Medical Thoracoscopy Group | Total |
|---|---|---|---|
| Count of participants | 12 | 12 | 24 |
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Tulane University