Early Intrapleural TPA Instillation Versus Late (ELEVATE)
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|ClinicalTrials.gov Identifier: NCT03167281|
Recruitment Status : Terminated (lack of adequate recruitment)
First Posted : May 25, 2017
Last Update Posted : March 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Tissue Plasminogen Activator||Combination Product: early tPA and DNase||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Intrapleural TPA Instillation Versus Late|
|Actual Study Start Date :||February 17, 2017|
|Actual Primary Completion Date :||March 10, 2021|
|Actual Study Completion Date :||March 10, 2021|
No Intervention: tPA and DNase
10mg of t-PA and 5 mg of DNase in a 30 mL solution of water/saline administered via chest tube over three days twice daily 24-48 hours after chest tube placed.
Experimental: Early tPA and DNase
10mg of t-PA and 5 mg of DNase in a 30 mL solution of water/saline administered via chest tube over three days twice daily with initial administration occurring at chest tube placement.
Combination Product: early tPA and DNase
Early addition of tPA and DNase (immediately at chest tube placement) versus later (24-48 hours) after chest tube placement.
- Chest tube removal [ Time Frame: 7 days ]Time to chest tube removal
- Fluid drainage [ Time Frame: 3 days ]Volume of fluid drained after each tPA and DNase instillation
- Need for other interventions [ Time Frame: 4 days ]Post tPA/DNase administration, the need for other interventions, such as surgery or additional chest tube, will be determined.
- Discharge [ Time Frame: 3 weeks ]Time to discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167281
|United States, South Carolina|
|Palmetto Health Richland|
|Columbia, South Carolina, United States, 29203|
|Principal Investigator:||Rohan Mankikar, MD||Prisma Health-Midlands|