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
38 studies on the registry are indexed under Empyema; 11 are open to participants now.
This study's enrollment of 32 is below the median of 92 across 28 interventional studies indexed under Empyema.
Browse Empyema studies →Tulane University is the lead sponsor of 96 studies on the registry; 23 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Drug page: Tissue Plasminogen Activator
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Dec 2019, 25 months.
Results were first posted in Feb 2021, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tissue Plasminogen Activator
Tulane University