An interventional study of VATS Decortication and Fibrinolytic Therapy in Parapneumonic Effusion, Empyema, Pleural and Coagulopathy, sponsored by Denver Health and Hospital Authority. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by Denver Health and Hospital Authority · Not applicable, Interventional, and Treatment
This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus fibrinolytic therapy. During treatment, the patient's coagulopathy status will also be evaluated.
The treatment of parapneumonic infections (infection in the pleural space) at the Denver Health Medical Center is not standardized, and timing for advanced interventions such as fibrinolytic therapy or surgical decortication remain unclear. The definitive treatment strategy in these patients may be sub-optimal, and lead to prolonged hospitalization and morbidity. This is concerning as the mortality rate of community acquired pneumonia triples in the presence of a parapneumonic process (5-15%) and can reach over 25% if it becomes bilateral(1). Prompt recognition of pleural space infections is essential for reducing morbidity and mortality. This is attributable to the progression of the disease from a simple fluid collection amenable to pleural space drainage, to necrotizing empyema requiring thoracotomy decortication and open drainage. The keys to management of parapneumonic effusions are early diagnosis, appropriate therapeutic intervention, and recognition of failure of conservative management. The investigators propose that a standardized pathway for identifying and treating parapneumonic effusions will be an important quality improvement. A key gap in the literature remains if patients with parapneumonic infections that cannot be drained with a chest tube should undergo a trial in intrapleural fibrinolytic therapy, or if they should go directly to video assisted thoracic surgery (VATS) for decortication of all infectious material.
33 studies on the registry are indexed under Empyema, Pleural; 11 are open to participants now.
This study's enrollment of 10 is below the median of 77 across 26 interventional studies indexed under Empyema, Pleural.
Browse Empyema, Pleural studies →Denver Health and Hospital Authority is the lead sponsor of 84 studies on the registry; 4 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
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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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema
Procedure: VATS Decortication
Non-operative group that will undergo instillation of the drugs DNAse and tPA (tissue plasminogen activator) together i.e. 5mg DNAse and 10mg tPA twice a day for up to six doses, through chest tube as treatment of the patient's complicated parapneumonic effusion/empyema. Fibrinolytic therapy = DNAse + tPA; these medications are not mutually exclusive.
Drug: Fibrinolytic Therapy
Surgical procedure to unroof all located collections of the pleural space through a chest wall incision
Instillation of DNAse and tPA together through patient's chest tube already in placed to break down complex fluid collection in the pleural space. DNAse and tPA are are administered together only i.e. are not mutually exclusive.
Also known as: DNAse / tPA combination therapy.
Hospital Length of Stay
How long the patient remains admitted in the hospital during their index hospitalization
Time frame: From patient's admission to hospital to their discharge, (excluding extended stay due to social work reasons) up to 28 days or discharge, which ever comes first.
ICU Free Days
Admission days during index hospitalization that are of a lower acuity of care than intensive care
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Chest Tube Days
Days with chest tube in place after intervention
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Cost of Admission and Treatment
Cost of care for the patient after their intervention
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Pain Score
What the patient's level of pain is from 0 to 10; zero being no pain, 10 being the worst pain imaginable. score is categorical 0,1,2,3,4,5,6,7,8,9 or 10.
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Chest Tube Drainage
The amount and character of the drainage from the chest tube after intervention
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Incentive Spirometry
To what volume the patient can inspire using an incentive spirometer
Time frame: Everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.
Supplemental Oxygen Days
The amount of time the patient needs to warn off any supplemental oxygen
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Fever Days
The amount of days it takes to resolve fever (temp \>100.4)
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Days of Antibiotics
The number of days antibiotics are required after intervention
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Elevated White Blood Count Days
The amount of days it takes to resolve a leukocytosis
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Changed in Coagulopathic Status
Changes in laboratory TEG values after intervention
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Prospective randomized clinical trial of hospitalized patients identified to have complicated parapneumonic effusions with radiographic imaging. Denver Health and Hospital Authority.
| Milestone | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
How long the patient remains admitted in the hospital during their index hospitalization
| days | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| Hospital Length of Stay | 12.4 ± 16.7 | 8.4 ± 4.1 |
Admission days during index hospitalization that are of a lower acuity of care than intensive care
| Days | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| ICU Free Days | 22.4 ± 8 | 20 ± 6.2 |
Days with chest tube in place after intervention
| Days | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| Chest Tube Days | 7.4 ± 8.2 | 8.2 ± 2.4 |
Cost of care for the patient after their intervention
No measurements were reported for this outcome.
What the patient's level of pain is from 0 to 10; zero being no pain, 10 being the worst pain imaginable. score is categorical 0,1,2,3,4,5,6,7,8,9 or 10.
| score on a scale | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| Pain Score | 3.6 ± 1 | 4.6 ± 2 |
The amount and character of the drainage from the chest tube after intervention
| mL | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| Chest Tube Drainage | 60.1 ± 12.3 | 713.2 ± 180.3 |
To what volume the patient can inspire using an incentive spirometer
No measurements were reported for this outcome.
The amount of time the patient needs to warn off any supplemental oxygen
| Days | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| Supplemental Oxygen Days | 17.8 ± 24.5 | 9.6 ± 2.3 |
The amount of days it takes to resolve fever (temp \>100.4)
| Days | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| Fever Days | 4.8 ± 5.3 | 0.8 ± 1.1 |
The number of days antibiotics are required after intervention
| Days | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| Days of Antibiotics | 17 ± 9.3 | 25.6 ± 24.6 |
The amount of days it takes to resolve a leukocytosis
| Days | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| Elevated White Blood Count Days | 5.6 ± 4 | 6 ± 3.6 |
Changes in laboratory TEG values after intervention
No measurements were reported for this outcome.
Collected over Through study completion, average of 1 year, which was the length of time participants were followed.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Operative VATS Decortication | 0/5 (0%) | 0/5 (0%) | 2/5 (40%) |
| Non-operative Fibrinolytic Therapy | 1/5 (20%) | 2/5 (40%) | 1/5 (20%) |
| Event | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| altered mental stateGeneral disorders | 0/5 | 2/5 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 0/5 | 1/5 |
| unplanned readmissionRespiratory, thoracic and mediastinal disorders | 0/5 | 1/5 |
| Event | Operative VATS Decortication | Non-operative Fibrinolytic Therapy |
|---|---|---|
| additional CTRespiratory, thoracic and mediastinal disorders | 2/5 | 1/5 |
10 subjects were enrolled. Five were randomized to the FT group and 5 to early VATS decortication.
| Age, Continuous(years) | Operative VATS Decortication | Non-operative Fibrinolytic Therapy | Total |
|---|---|---|---|
| Mean | 44 ± 16.1 | 45.6 ± 11.1 | 44.8 ± 13.6 |
| Sex: Female, Male(Participants) | Operative VATS Decortication | Non-operative Fibrinolytic Therapy | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 4 | 3 | 7 |
| Race and Ethnicity Not Collected(Participants) | Operative VATS Decortication | Non-operative Fibrinolytic Therapy | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2018 to primary completion in Feb 2020, 18 months.
Results were first posted in Jan 2022, 1 year 11 months after primary completion.
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Denver Health and Hospital Authority