Parapneumonic EffusionNCT03583931
Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication
A study testing VATS Decortication and Fibrinolytic Therapy in people with Parapneumonic Effusion and Empyema, Pleural, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parapneumonic Effusion, Empyema, Pleural, Coagulopathy
- What is being tested?
- VATS Decortication and Fibrinolytic Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2018to 2 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and older
- Admitted with pleural effusion that undergoes thoracentesis by medical/pulmonary service
- Pleural fluid pH <7.3
- SICU placed chest tube
- Subsequent transfer to SICU
Who cannot join
- Existing malignancy
- Malignant cells from initial pleural fluid sample
- End stage liver disease (Child's B or greater)
- Coagulopathy
- Unable to tolerate surgical procedure
- Frank purulent drainage (needs OR regardless)
- Recent surgery of abdomen or thorax precluding the use of tPA
- Baseline neurologic impairment requiring a proxy for consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Intervention for Complicated Parapneumonic Effusion: Randomized Controlled Trial for Fibrinolytic Therapy Versus VATs Decortication
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.
Read the detailed description
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.
- Conditions
- Parapneumonic Effusion, Empyema, Pleural, Coagulopathy
- Being tested
- VATS Decortication, Fibrinolytic Therapy
- Keywords
- VATS Decortication, Surgical Pleural Decortication, Fibrinolytic Therapy, Pneumonia, Thoracostomy
- Medical subject headings
- Empyema, Pleural, Hemostatic Disorders, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS DecorticationProcedure or surgery
Surgical procedure to unroof all located collections of the pleural space through a chest wall incision
Fibrinolytic TherapyDrug
Also called DNAse / tPA combination therapy.
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.
| Study group | Role | What they receive |
|---|---|---|
| Operative VATS decortication | Active comparator | Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema Receives: Procedure: VATS Decortication |
| Non-operative Fibrinolytic Therapy | Active comparator | 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. Receives: Drug: Fibrinolytic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
How long the patient remains admitted in the hospital during their index hospitalization
Measured: 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.
Secondary outcomes (11)
ICU Free Days
Admission days during index hospitalization that are of a lower acuity of care than intensive care
Measured: From admission to discharge, or for 28 days, whichever comes first.
Chest Tube Days
Days with chest tube in place after intervention
Measured: 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
Measured: 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.
Measured: 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
Measured: From admission to discharge, or for 28 days, whichever comes first.
Incentive Spirometry
To what volume the patient can inspire using an incentive spirometer
Measured: 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
Measured: 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)
Measured: From admission to discharge, or for 28 days, whichever comes first.
Days of Antibiotics
The number of days antibiotics are required after intervention
Measured: 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
Measured: From admission to discharge, or for 28 days, whichever comes first.
Changed in Coagulopathic Status
Changes in laboratory TEG values after intervention
Measured: From admission to discharge, or for 28 days, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start26 Jul 2018
- Primary completion2 Feb 2020
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parapneumonic EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fredric Pieracci, MD, MPH, Principal investigator, Denver Health and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583931
- Sponsor's protocol ID
- 17-0857
- Status last verified
- Nov 2021
- First submitted
- 11 May 2018
- Last updated
- 27 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barrett CD, Moore PK, Moore EE, Moore HB, Chandler JG, Siddiqui H, Maginot ER, Sauaia A, Perez-Calatayud AA, Buesing K, Wang J, Davila-Chapa C, Hershberger D, Douglas I, Pieracci FM, Yaffe MB. Neutrophil-Mediated Inflammatory Plasminogen Degradation, Rather Than High Plasminogen-Activator Inhibitor-1, May Underly Failures and Inefficiencies of Intrapleural Fibrinolysis. Chest. 2025 Jan;167(1):67-75. doi: 10.1016/j.chest.2024.04.005. Epub 2024 May 6.
PubMed 38710463
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention for Complicated Parapneumonic Effusion: Randomized Controlled Trial for Fibrinolytic Therapy Versus VATs Decortication
- ClinicalTrials.gov ID
- NCT03583931
- Acronym / sponsor ID
- 17-0857
- Conditions
- Parapneumonic Effusion, Empyema, Pleural, Coagulopathy
- Keywords
- VATS Decortication, Surgical Pleural Decortication, Fibrinolytic Therapy, Pneumonia, Thoracostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Posted 27 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Operative VATS decortication | Active comparator | Procedure: VATS DecorticationOperative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema |
| Non-operative Fibrinolytic Therapy | Active comparator | Drug: Fibrinolytic TherapyNon-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old and older
- Admitted with pleural effusion that undergoes thoracentesis by medical/pulmonary service
- Pleural fluid pH <7.3
- SICU placed chest tube
- Subsequent transfer to SICU
Key exclusion criteria (8 listed)
- Existing malignancy
- Malignant cells from initial pleural fluid sample
- End stage liver disease (Child's B or greater)
- Coagulopathy
- Unable to tolerate surgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VATS DecorticationSurgical procedure to unroof all located collections of the pleural space through a chest wall incision | Procedure or surgery | Operative VATS decortication |
| Fibrinolytic TherapyAlso: DNAse / tPA combination therapy.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. | Drug | Non-operative Fibrinolytic Therapy |
Primary outcome
Hospital Length of Stay
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.
How long the patient remains admitted in the hospital during their index hospitalization
11 secondary outcomes
ICU Free Days
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Chest Tube Days
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Cost of Admission and Treatment
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Pain Score
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Chest Tube Drainage
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Incentive Spirometry
Time frame: Everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.
Supplemental Oxygen Days
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Fever Days
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Days of Antibiotics
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Elevated White Blood Count Days
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Changed in Coagulopathic Status
Time frame: From admission to discharge, or for 28 days, whichever comes first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38710463Barrett CD, Moore PK, Moore EE, Moore HB, Chandler JG, Siddiqui H, Maginot ER, Sauaia A, Perez-Calatayud AA, Buesing K, Wang J, Davila-Chapa C, Hershberger D, Douglas I, Pieracci FM, Yaffe MB. Neutrophil-Mediated Inflammatory Plasminogen Degradation, Rather Than High Plasminogen-Activator Inhibitor-1, May Underly Failures and Inefficiencies of Intrapleural Fibrinolysis. Chest. 2025 Jan;167(1):67-75. doi: 10.1016/j.chest.2024.04.005. Epub 2024 May 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredric Pieracci, MD, MPH principal investigator
Denver Health and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VATS Decortication and Fibrinolytic Therapy in people with Parapneumonic Effusion and Empyema, Pleural, run by Denver Health and Hospital Authority at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of Stay (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03583931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.