Trial Outcomes & Findings for Fibrinolytic Therapy Versus Medical Thoracoscopy (NCT NCT03213834)
NCT ID: NCT03213834
Last Updated: 2024-02-20
Results Overview
Time between initiation of treatment and hospital discharge
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
30 days starting on day of admission
Results posted on
2024-02-20
Participant Flow
The study participants comprised a convenience sample of adults with CPPE or empyema who presented to the UFHealth pulmonary medicine service, met all inclusion / exclusion criteria, and agreed to participate.
After consent, but prior to randomization, all participants underwent diagnostic thoracentesis and confirmation of pleural infection.
Participant milestones
| Measure |
Thoracoscopy Arm
Consisting of chest thoracoscopy
Chest thoracoscopy: Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction
|
Fibrinolytic Therapy Arm
Consisting of chest fibrinolytic therapy
Chest fibrinolytic therapy: A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
tPA: tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
DNase: DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
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 |
Thoracoscopy Arm
n=3 Participants
Consisting of chest thoracoscopy
Chest thoracoscopy: Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction
|
Fibrinolytic Therapy Arm
n=2 Participants
Consisting of chest fibrinolytic therapy
Chest fibrinolytic therapy: A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
tPA: tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
DNase: DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
2 participants
n=2 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days starting on day of admissionTime between initiation of treatment and hospital discharge
Outcome measures
| Measure |
Thoracoscopy Arm
n=3 Participants
Consisting of chest thoracoscopy
Chest thoracoscopy: Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction
|
Fibrinolytic Therapy Arm
n=2 Participants
Consisting of chest fibrinolytic therapy
Chest fibrinolytic therapy: A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
tPA: tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
DNase: DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
|
|---|---|---|
|
Number of Hospital Days for Required to Treat Complicated Parapneumonic Effusions or Pleural Empyema.
|
13 days
Interval 7.0 to 16.0
|
18.5 days
Interval 15.0 to 22.0
|
SECONDARY outcome
Timeframe: 30 days starting on day of admissionThe number of days, during the hospital admission, where the patient demonstrated chest tube drainage
Outcome measures
| Measure |
Thoracoscopy Arm
n=3 Participants
Consisting of chest thoracoscopy
Chest thoracoscopy: Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction
|
Fibrinolytic Therapy Arm
n=2 Participants
Consisting of chest fibrinolytic therapy
Chest fibrinolytic therapy: A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
tPA: tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
DNase: DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
|
|---|---|---|
|
Duration of Chest Tube
|
13 days
Interval 6.0 to 13.0
|
7 days
Interval 6.0 to 8.0
|
SECONDARY outcome
Timeframe: 30 days starting on day of admissionNumber of days patient registered as in-house for treatment of pleural infection
Outcome measures
| Measure |
Thoracoscopy Arm
n=3 Participants
Consisting of chest thoracoscopy
Chest thoracoscopy: Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction
|
Fibrinolytic Therapy Arm
n=2 Participants
Consisting of chest fibrinolytic therapy
Chest fibrinolytic therapy: A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
tPA: tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
DNase: DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
|
|---|---|---|
|
Duration of Entire Hospital Stay for Complete Treatment of Pleural Infection
|
13 days
Interval 7.0 to 16.0
|
18.5 days
Interval 15.0 to 22.0
|
SECONDARY outcome
Timeframe: 30 days starting on day of admissionFollowing intervention, if patient requires (1) surgical intervention (VATS, open thoracotomy), (2) an additional chest tube, or (3) a repeat procedure
Outcome measures
| Measure |
Thoracoscopy Arm
n=3 Participants
Consisting of chest thoracoscopy
Chest thoracoscopy: Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction
|
Fibrinolytic Therapy Arm
n=2 Participants
Consisting of chest fibrinolytic therapy
Chest fibrinolytic therapy: A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
tPA: tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
DNase: DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
|
|---|---|---|
|
Treatment Failure
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days starting on day of admissionNumber of participants who experienced documented adverse events during their hospital stays
Outcome measures
| Measure |
Thoracoscopy Arm
n=3 Participants
Consisting of chest thoracoscopy
Chest thoracoscopy: Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction
|
Fibrinolytic Therapy Arm
n=2 Participants
Consisting of chest fibrinolytic therapy
Chest fibrinolytic therapy: A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
tPA: tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
DNase: DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 days starting on day of admissionIn hospital and 30 day mortality measures
Outcome measures
| Measure |
Thoracoscopy Arm
n=3 Participants
Consisting of chest thoracoscopy
Chest thoracoscopy: Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction
|
Fibrinolytic Therapy Arm
n=2 Participants
Consisting of chest fibrinolytic therapy
Chest fibrinolytic therapy: A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
tPA: tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
DNase: DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
|
|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
Adverse Events
Thoracoscopy Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fibrinolytic Therapy Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Erin Silverman, Research Coordinator
University of Florida
Phone: 352-273-5870
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place