Early Intrapleural TPA Instillation Versus Late

NCT03167281 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 00058518
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Chest tubes are used for air or fluid removal from the pleural space. When a chest tube is placed, it can be hard for the fluid to drain.Tissue plasminogen activator (tPA) and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase immediately after chest tube placement will help with better fluid draining.

Conditions

Tissue Plasminogen Activator

Keywords

Chest tube; Thoracostomy; Pleural Diseases; Lung Neoplasms; Pulmonary Embolism; Pneumothorax; Thoracic Surgery; Deoxyribonucleases; Fibrinolytic Agents; Drainage; Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• Chest tube removal

  Time to chest tube removal

  7 days

Secondary Outcomes (3)

• Fluid drainage

  3 days

• Need for other interventions

  4 days

• Discharge

  3 weeks

Study Arms (2)

tPA and DNase

NO INTERVENTION

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.

Early tPA and DNase

EXPERIMENTAL

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

Interventions

early tPA and DNase COMBINATION_PRODUCT

Early addition of tPA and DNase (immediately at chest tube placement) versus later (24-48 hours) after chest tube placement.

Early tPA and DNase

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, age 18 years or older
• Patients with an indication for a thoracostomy tube placement for a pleural effusion

You may not qualify if:

• Patients that require a thoracostomy tube for a pneumothorax
• Pregnant women
• Sensitivity to t-PA, or DNase
• Patients taking carbamazepine or nitroglycerin
• Lung volume reduction surgery on side of pleural effusion

Sponsors & Collaborators

• Prisma Health-Midlands: lead

Study Sites (1)

Palmetto Health Richland

Columbia, South Carolina, 29203, United States

Location

Related Links

• South Carolina Research Studies Directory

MeSH Terms

Conditions

Pleural Diseases; Lung Neoplasms; Pulmonary Embolism; Pneumothorax; Pleural Effusion

Interventions

Deoxyribonucleases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Rohan Mankikar, MD

  Prisma Health-Midlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 25, 2017
• Study Start: February 17, 2017
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)