Trial Outcomes & Findings for Fibrinolysis Compared to Thoracoscopy for Pleural Infection (NCT NCT03468933)
NCT ID: NCT03468933
Last Updated: 2021-02-04
Results Overview
duration of hospital stay in days from time of procedure to discharge from hospital.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
12 week follow up period
Results posted on
2021-02-04
Participant Flow
Participant milestones
| Measure |
Fibrinolytic Therapy Group
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
|
Medical Thoracoscopy Group
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
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 |
Fibrinolytic Therapy Group
n=16 Participants
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
|
Medical Thoracoscopy Group
n=16 Participants
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=16 Participants
|
65 years
n=16 Participants
|
64 years
n=32 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=16 Participants
|
2 Participants
n=16 Participants
|
8 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=16 Participants
|
14 Participants
n=16 Participants
|
24 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
|
Ultrasonographic estimated pleural effusion volume,Moderate
|
13 Participants
n=16 Participants
|
13 Participants
n=16 Participants
|
26 Participants
n=32 Participants
|
|
Number of subjects with community acquired pleural infection
|
12 Participants
n=16 Participants
|
12 Participants
n=16 Participants
|
24 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: 12 week follow up periodPopulation: All participants received one of the assigned intervention
duration of hospital stay in days from time of procedure to discharge from hospital.
Outcome measures
| Measure |
Fibrinolytic Therapy Group
n=16 Participants
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
|
Medical Thoracoscopy Group
n=16 Participants
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.
|
|---|---|---|
|
Duration of Hospital Stay After Intervention
|
4 days
Interval 4.0 to 5.5
|
2 days
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 12 week follow up periodPopulation: All participants received assigned intervention
Total days spent in the hospital
Outcome measures
| Measure |
Fibrinolytic Therapy Group
n=16 Participants
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
|
Medical Thoracoscopy Group
n=16 Participants
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.
|
|---|---|---|
|
Total Length of Hospital Stay
|
6 days
Interval 5.0 to 8.5
|
3.5 days
Interval 2.0 to 10.0
|
SECONDARY outcome
Timeframe: 12 week follow up periodPopulation: All participants received assigned intervention
1. Need for surgical intervention (VATS, Open Thoracotomy) in any arm 2. Need for additional chest tube and/or fibrinolytic therapy in the medical thoracoscopy arm due to treatment failure 3. Need of additional chest tube or additional fibrinolytic doses in the fibrinolytic therapy arm due to treatment failure
Outcome measures
| Measure |
Fibrinolytic Therapy Group
n=16 Participants
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
|
Medical Thoracoscopy Group
n=16 Participants
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.
|
|---|---|---|
|
Number of Participants Necessitating Intervention After the Assigned Treatment
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 week follow up periodPopulation: All participants received assigned intervention
any Adverse events (pain, bleeding)
Outcome measures
| Measure |
Fibrinolytic Therapy Group
n=16 Participants
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
|
Medical Thoracoscopy Group
n=16 Participants
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.
|
|---|---|---|
|
Adverse Events
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: All participants received assigned intervention
Death of a patient while being hospitalized or up to 30 days after
Outcome measures
| Measure |
Fibrinolytic Therapy Group
n=16 Participants
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
|
Medical Thoracoscopy Group
n=16 Participants
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.
|
|---|---|---|
|
In Hospital and 30-day Mortality
|
0 Participants
|
1 Participants
|
Adverse Events
Fibrinolytic Therapy Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Medical Thoracoscopy Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fibrinolytic Therapy Group
n=16 participants at risk
Patients randomized to the Fibrinolytic group will receive intrapleural therapy of combined tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase) via chest tube.
tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase): Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
|
Medical Thoracoscopy Group
n=16 participants at risk
Patients randomized to the Thoracoscopy group will undergo medical thoracoscopy.
Medical Thoracoscopy: Medical thoracoscopy will be performed as per standard protocols.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
6.2%
1/16 • Number of events 1 • The perioperative period until hospital discharge, an average of 4 weeks per participant
Definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov.
|
6.2%
1/16 • Number of events 1 • The perioperative period until hospital discharge, an average of 4 weeks per participant
Definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place