Early Intrapleural TPA Instillation Versus Late (ELEVATE)
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|ClinicalTrials.gov Identifier: NCT03167281|
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : September 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tissue Plasminogen Activator||Combination Product: early tPA and DNase||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Intrapleural TPA Instillation Versus Late|
|Actual Study Start Date :||February 17, 2017|
|Estimated Primary Completion Date :||February 16, 2020|
|Estimated Study Completion Date :||February 16, 2020|
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
|Contact: Rohan Mankikar, MDfirstname.lastname@example.org|
|Contact: Rohan Arya, MDemail@example.com|
|United States, South Carolina|
|Palmetto Health Richland||Recruiting|
|Columbia, South Carolina, United States, 29203|
|Contact: Principal Investigator|
|Principal Investigator:||Rohan Mankikar, MD||Palmetto Health|