Clinical Trial: Tenecteplase (TNK) for Loculated Pleural Effusions in Patients With Malignancy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: TNK for Loculated Pleural Effusions in Patients With Malignancy

Brief Summary: The objective of the study is to determine the safety and efficacy of TNK infusion for the treatment of loculated pleural effusions in patients with known malignancy compared to normal saline infusion.

Detailed Summary: The design of the trial will be as a single-center, prospective, blinded, randomized trial comparing the infusion of TNKase versus saline for treatment of symptomatic loculated pleural effusion in patients with malignancy. Patients with known malignancy and symptomatic loculated pleural effusion who are referred for percutaneous drainage will be eligible for this study. Patients will undergo standard placement of a 8-10 french percutaneous drain into their pleural space under computed tomography or ultrasound guidance. If there is incomplete drainage of the pleural fluid at the time of initial catheter placement or if followup chest radiography performed within 24-48 hours of chest tube placement reveals persistent pleural fluid, the effusion will be considered to be loculated. After informed consent, patients will be alternately randomized to a 3 day course of twice a day intrapleural TNKase or sterile saline injections. Both the patient and the patient's primary care physician will be blinded as to the infusate. The test fluid will be kept with the pleural space for a minimum of 2 hrs before the drainage tube is returned to suction. The standard dose of TNKase will be 4 mg/60 ml NS. The control group will received 60 ml NS for each infusion. There will be a cross-over design so that patients who fail to have significant drainage during the first 2 days of therapy may be switched to the other infusate for up to an additional three days (at the primary care provider's discretion). Thus, patients who are in the saline arm will be switched to TNKase if there is a symptomatic persistent residual loculated effusion and those who fail TNKase will be switched to saline after 2 days. This is necessary in order for primary care providers to allow their patients to be enrolled in this study since our standard of care is to use Activase. We will use a cutoff of 2 days rather than 3 days before switching therapy because we cannot justify the expense of keeping patients hospita
Sponsor: Kaiser Permanente

Current Primary Outcome:

• Percentage of Patients Achieving Complete or Near Complete Drainage of Loculated Pleural Effusion as Determined From Chest Radiography After Three Days or Five Days of Intrapleural Therapy. [ Time Frame: 3-5 days ]
• Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage [ Time Frame: 3-5 days ]
  This is the percentage of patients in each arm of the study (Normal saline or TNKase) who suffered a hemorrhagic complication directly associated with instillation of normal saline or TNKase

Original Primary Outcome:

• Percentage of Patients Achieving Complete or Near Complete Drainage of Loculated Pleural Effusion as Determined From Chest Radiography After Three Days or Five Days of Intrapleural Therapy. [ Time Frame: 3-5 days ]
• Hemorrhagic complications associated with catheter drainage [ Time Frame: 3-5 days ]

Current Secondary Outcome:

• Percentage of Patients Who Fail Initial Therapy (TNK or Saline) Who at the Request of the Hospital-based Doctor Are Then Switched to the Other Arm/Group AND Who Then Achieve Satisfactory Drainage (Saline or TNK) Therapy. [ Time Frame: 3-5 days ]
  Only one patient who was on normal saline arm/group was switched (by request of the referring hospital-based doctor) to TNKase, but did not have complete clearing of their effusion. No patient in the TNKase arm/group was switched to normal saline. Therefore, we have removed the TNKase arm/group from this portion of the analysis since there are no participants in this group to analyze this outcome measure.
• Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion. [ Time Frame: 30 days ]
• Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion [ Time Frame: 30 days ]
  This measures the number of hospital days for each participant after they were started on their infusion therapy.

Original Secondary Outcome:

• Percent of patients who fail initial therapy (TNK or saline) who achieve satisfactory drainage after switching to the alternative (saline or TNK) therapy. [ Time Frame: 3-5 days ]
• Percent of patients able to undergo pleurodesis to prevent recurrent pleural effusion. [ Time Frame: 30 days ]
• Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion [ Time Frame: 30 days ]

Dates:
Date Received: September 17, 2010
Date Started: January 2008
Date Completion:
Last Updated: January 2, 2015
Last Verified: January 2015