Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication

• Sponsor: Denver Health and Hospital Authority (Other)
• Overall Status: Completed
• CT.gov ID: NCT03583931
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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. During treatment, the patient's coagulopathy status will also be evaluated.

Condition or Disease	Intervention/Treatment	Phase
Parapneumonic Effusion; Empyema, Pleural; Coagulopathy	Procedure: VATS Decortication; Drug: Fibrinolytic Therapy	N/A

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

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective Randomized Clinical TrialProspective Randomized Clinical Trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Intervention for Complicated Parapneumonic Effusion: Randomized Controlled Trial for Fibrinolytic Therapy Versus VATs Decortication
• Actual Study Start Date: Jul 26, 2018
• Actual Primary Completion Date: Feb 2, 2020
• Actual Study Completion Date: Feb 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Operative VATS decortication Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema	Procedure: VATS Decortication; Surgical procedure to unroof all located collections of the pleural space through a chest wall incision
Active Comparator: Non-operative Fibrinolytic Therapy 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; 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.; Other Names: DNAse / tPA combination therapy.

Outcome Measures

Primary Outcome Measures

1. Hospital Length of Stay [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

Secondary Outcome Measures

1. ICU Free Days [From admission to discharge, or for 28 days, whichever comes first.]

   Admission days during index hospitalization that are of a lower acuity of care than intensive care

2. Chest Tube Days [From admission to discharge, or for 28 days, whichever comes first.]

   Days with chest tube in place after intervention

3. Cost of Admission and Treatment [From admission to discharge, or for 28 days, whichever comes first.]

   Cost of care for the patient after their intervention

4. Pain Score [From admission to discharge, or for 28 days, whichever comes first.]

   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.

5. Chest Tube Drainage [From admission to discharge, or for 28 days, whichever comes first.]

   The amount and character of the drainage from the chest tube after intervention

6. Incentive Spirometry [Everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.]

   To what volume the patient can inspire using an incentive spirometer

7. Supplemental Oxygen Days [From admission to discharge, or for 28 days, whichever comes first.]

   The amount of time the patient needs to warn off any supplemental oxygen

8. Fever Days [From admission to discharge, or for 28 days, whichever comes first.]

   The amount of days it takes to resolve fever (temp >100.4)

9. Days of Antibiotics [From admission to discharge, or for 28 days, whichever comes first.]

   The number of days antibiotics are required after intervention

10. Elevated White Blood Count Days [From admission to discharge, or for 28 days, whichever comes first.]

    The amount of days it takes to resolve a leukocytosis

11. Changed in Coagulopathic Status [From admission to discharge, or for 28 days, whichever comes first.]

    Changes in laboratory TEG values after intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Denver Health	Denver	Colorado	United States	80204

Sponsors and Collaborators

• Denver Health and Hospital Authority

Investigators

• Principal Investigator: Fredric Pieracci, MD, MPH, Denver Health and Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 30, 2019

More Information

Publications

None provided.

• Responsible Party: Denver Health and Hospital Authority
• ClinicalTrials.gov Identifier: NCT03583931
• Other Study ID Numbers: 17-0857
• First Posted: Jul 12, 2018
• Last Update Posted: Jan 27, 2022
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Denver Health and Hospital Authority: VATS Decortication; Surgical Pleural Decortication; Fibrinolytic Therapy; Pneumonia; Thoracostomy
• Additional relevant MeSH terms: Empyema; Empyema, Pleural

Study Results

Participant Flow

Recruitment Details	Prospective randomized clinical trial of hospitalized patients identified to have complicated parapneumonic effusions with radiographic imaging. Denver Health and Hospital Authority.

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Period Title: Overall Study
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy	Total
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.	Total of all reporting groups
Overall Participants	5	5	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44 (16.1)	45.6 (11.1)	44.8 (13.6)
Sex: Female, Male (Count of Participants)
Female	1 20%	2 40%	3 30%
Male	4 80%	3 60%	7 70%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Hospital Length of Stay
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	5	5
Mean (Standard Deviation) [days]	12.4 (16.7)	8.4 (4.1)

2. Secondary Outcome

Title	ICU Free Days
Description	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.

Outcome Measure Data

Analysis Population Description

All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	5	5
Mean (Standard Deviation) [Days]	22.4 (8)	20 (6.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Operative VATS Decortication, Non-operative Fibrinolytic Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments
	Method	ANOVA
	Comments

3. Secondary Outcome

Title	Chest Tube Days
Description	Days with chest tube in place after intervention
Time Frame	From admission to discharge, or for 28 days, whichever comes first.

Outcome Measure Data

Analysis Population Description

All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	5	5
Mean (Standard Deviation) [Days]	7.4 (8.2)	8.2 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Operative VATS Decortication, Non-operative Fibrinolytic Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.84
	Comments
	Method	ANOVA
	Comments

4. Secondary Outcome

Title	Cost of Admission and Treatment
Description	Cost of care for the patient after their intervention
Time Frame	From admission to discharge, or for 28 days, whichever comes first.

Outcome Measure Data

Analysis Population Description

The data were not collected

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	0	0

5. Secondary Outcome

Title	Pain Score
Description	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.

Outcome Measure Data

Analysis Population Description

The pain score was provided at the discharge date or at 28 days of admission (whichever came first).

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	4	5
Mean (Standard Deviation) [score on a scale]	3.6 (1)	4.6 (2)

6. Secondary Outcome

Title	Chest Tube Drainage
Description	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.

Outcome Measure Data

Analysis Population Description

Incomplete analysis documented in records on this measure.

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	4	5
Mean (Standard Deviation) [mL]	60.1 (12.3)	713.2 (180.3)

7. Secondary Outcome

Title	Incentive Spirometry
Description	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.

Outcome Measure Data

Analysis Population Description

No participants were analyzed on this measure in the final analysis, because the data were not collected.

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	0	0

8. Secondary Outcome

Title	Supplemental Oxygen Days
Description	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.

Outcome Measure Data

Analysis Population Description

All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	5	5
Mean (Standard Deviation) [Days]	17.8 (24.5)	9.6 (2.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Operative VATS Decortication, Non-operative Fibrinolytic Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.48
	Comments
	Method	ANOVA
	Comments

9. Secondary Outcome

Title	Fever Days
Description	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.

Outcome Measure Data

Analysis Population Description

All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	5	5
Mean (Standard Deviation) [Days]	4.8 (5.3)	0.8 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Operative VATS Decortication, Non-operative Fibrinolytic Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	ANOVA
	Comments

10. Secondary Outcome

Title	Days of Antibiotics
Description	The number of days antibiotics are required after intervention
Time Frame	From admission to discharge, or for 28 days, whichever comes first.

Outcome Measure Data

Analysis Population Description

All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	5	5
Mean (Standard Deviation) [Days]	17 (9.3)	25.6 (24.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Operative VATS Decortication, Non-operative Fibrinolytic Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	ANOVA
	Comments

11. Secondary Outcome

Title	Elevated White Blood Count Days
Description	The amount of days it takes to resolve a leukocytosis
Time Frame	From admission to discharge, or for 28 days, whichever comes first.

Outcome Measure Data

Analysis Population Description

All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	5	5
Mean (Standard Deviation) [Days]	5.6 (4)	6 (3.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Operative VATS Decortication, Non-operative Fibrinolytic Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.87
	Comments
	Method	ANOVA
	Comments

12. Secondary Outcome

Title	Changed in Coagulopathic Status
Description	Changes in laboratory TEG values after intervention
Time Frame	From admission to discharge, or for 28 days, whichever comes first.

Outcome Measure Data

Analysis Population Description

No participants were analyzed on this measure in the final analysis, because the data were not collected.

Arm/Group Title	Operative VATS Decortication	Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision	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. Fibrinolytic 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.
Measure Participants	0	0

Adverse Events

Time Frame	Through study completion, average of 1 year, which was the length of time participants were followed.
Arm/Group Title	Operative VATS Decortication		Non-operative Fibrinolytic Therapy
Arm/Group Description	Operative group that will undergo early VATS decortication of complicated parapneumonic effusion/empyema VATS Decortication: Surgical procedure to unroof all located collections of the pleural space through a chest wall incision		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. Fibrinolytic 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.
All Cause Mortality
	Operative VATS Decortication		Non-operative Fibrinolytic Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		1/5 (20%)
Serious Adverse Events
	Operative VATS Decortication		Non-operative Fibrinolytic Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		2/5 (40%)
General disorders
altered mental state	0/5 (0%)		2/5 (40%)
Respiratory, thoracic and mediastinal disorders
Pneumothorax	0/5 (0%)		1/5 (20%)
unplanned readmission	0/5 (0%)		1/5 (20%)
Other (Not Including Serious) Adverse Events
	Operative VATS Decortication		Non-operative Fibrinolytic Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/5 (40%)		1/5 (20%)
Respiratory, thoracic and mediastinal disorders
additional CT	2/5 (40%)		1/5 (20%)

Limitations/Caveats

Potential limitations to this study include a small sample size.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.