Trial Outcomes & Findings for Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication (NCT NCT03583931)
NCT ID: NCT03583931
Last Updated: 2022-01-27
Results Overview
How long the patient remains admitted in the hospital during their index hospitalization
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
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.
Results posted on
2022-01-27
Participant Flow
Prospective randomized clinical trial of hospitalized patients identified to have complicated parapneumonic effusions with radiographic imaging. Denver Health and Hospital Authority.
Participant milestones
| Measure |
Operative VATS Decortication
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 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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Operative VATS Decortication
n=5 Participants
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 Fibrinolytic Therapy
n=5 Participants
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
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 13.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Operative VATS Decortication
n=5 Participants
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 Fibrinolytic Therapy
n=5 Participants
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.
|
|---|---|---|
|
Hospital Length of Stay
|
12.4 days
Standard Deviation 16.7
|
8.4 days
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: From admission to discharge, or for 28 days, whichever comes first.Population: All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.
Admission days during index hospitalization that are of a lower acuity of care than intensive care
Outcome measures
| Measure |
Operative VATS Decortication
n=5 Participants
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 Fibrinolytic Therapy
n=5 Participants
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.
|
|---|---|---|
|
ICU Free Days
|
22.4 Days
Standard Deviation 8
|
20 Days
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: From admission to discharge, or for 28 days, whichever comes first.Population: All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.
Days with chest tube in place after intervention
Outcome measures
| Measure |
Operative VATS Decortication
n=5 Participants
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 Fibrinolytic Therapy
n=5 Participants
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.
|
|---|---|---|
|
Chest Tube Days
|
7.4 Days
Standard Deviation 8.2
|
8.2 Days
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: From admission to discharge, or for 28 days, whichever comes first.Population: The data were not collected
Cost of care for the patient after their intervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From admission to discharge, or for 28 days, whichever comes first.Population: The pain score was provided at the discharge date or at 28 days of admission (whichever came 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.
Outcome measures
| Measure |
Operative VATS Decortication
n=4 Participants
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 Fibrinolytic Therapy
n=5 Participants
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.
|
|---|---|---|
|
Pain Score
|
3.6 score on a scale
Standard Deviation 1
|
4.6 score on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: From admission to discharge, or for 28 days, whichever comes first.Population: Incomplete analysis documented in records on this measure.
The amount and character of the drainage from the chest tube after intervention
Outcome measures
| Measure |
Operative VATS Decortication
n=4 Participants
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 Fibrinolytic Therapy
n=5 Participants
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.
|
|---|---|---|
|
Chest Tube Drainage
|
60.1 mL
Standard Deviation 12.3
|
713.2 mL
Standard Deviation 180.3
|
SECONDARY outcome
Timeframe: Everyday for 5 days post study intervention, from admission to discharge, or for 28 days, whichever comes first.Population: No participants were analyzed on this measure in the final analysis, because the data were not collected.
To what volume the patient can inspire using an incentive spirometer
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From admission to discharge, or for 28 days, whichever comes first.Population: All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.
The amount of time the patient needs to warn off any supplemental oxygen
Outcome measures
| Measure |
Operative VATS Decortication
n=5 Participants
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 Fibrinolytic Therapy
n=5 Participants
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.
|
|---|---|---|
|
Supplemental Oxygen Days
|
17.8 Days
Standard Deviation 24.5
|
9.6 Days
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: From admission to discharge, or for 28 days, whichever comes first.Population: All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.
The amount of days it takes to resolve fever (temp \>100.4)
Outcome measures
| Measure |
Operative VATS Decortication
n=5 Participants
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 Fibrinolytic Therapy
n=5 Participants
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.
|
|---|---|---|
|
Fever Days
|
4.8 Days
Standard Deviation 5.3
|
0.8 Days
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: From admission to discharge, or for 28 days, whichever comes first.Population: All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.
The number of days antibiotics are required after intervention
Outcome measures
| Measure |
Operative VATS Decortication
n=5 Participants
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 Fibrinolytic Therapy
n=5 Participants
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.
|
|---|---|---|
|
Days of Antibiotics
|
17 Days
Standard Deviation 9.3
|
25.6 Days
Standard Deviation 24.6
|
SECONDARY outcome
Timeframe: From admission to discharge, or for 28 days, whichever comes first.Population: All 10 participants were analyzed on this data point and aggregate data is provided below for each treatment arm.
The amount of days it takes to resolve a leukocytosis
Outcome measures
| Measure |
Operative VATS Decortication
n=5 Participants
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 Fibrinolytic Therapy
n=5 Participants
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.
|
|---|---|---|
|
Elevated White Blood Count Days
|
5.6 Days
Standard Deviation 4
|
6 Days
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: From admission to discharge, or for 28 days, whichever comes first.Population: No participants were analyzed on this measure in the final analysis, because the data were not collected.
Changes in laboratory TEG values after intervention
Outcome measures
Outcome data not reported
Adverse Events
Operative VATS Decortication
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-operative Fibrinolytic Therapy
Serious events: 2 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Operative VATS Decortication
n=5 participants at risk
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 Fibrinolytic Therapy
n=5 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/5 • Through study completion, average of 1 year, which was the length of time participants were followed.
|
20.0%
1/5 • Through study completion, average of 1 year, which was the length of time participants were followed.
|
|
General disorders
altered mental state
|
0.00%
0/5 • Through study completion, average of 1 year, which was the length of time participants were followed.
|
40.0%
2/5 • Through study completion, average of 1 year, which was the length of time participants were followed.
|
|
Respiratory, thoracic and mediastinal disorders
unplanned readmission
|
0.00%
0/5 • Through study completion, average of 1 year, which was the length of time participants were followed.
|
20.0%
1/5 • Through study completion, average of 1 year, which was the length of time participants were followed.
|
Other adverse events
| Measure |
Operative VATS Decortication
n=5 participants at risk
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 Fibrinolytic Therapy
n=5 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
additional CT
|
40.0%
2/5 • Through study completion, average of 1 year, which was the length of time participants were followed.
|
20.0%
1/5 • Through study completion, average of 1 year, which was the length of time participants were followed.
|
Additional Information
Dr Fredric Pieracci
Denver Health and Hospital Authority
Phone: 303-602-1863
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place