Tenecteplase (TNK) for Loculated Pleural Effusions in Patients With Malignancy
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|ClinicalTrials.gov Identifier: NCT01580618|
Recruitment Status : Terminated (Unable to accrue patients at a reasonable rate)
First Posted : April 19, 2012
Results First Posted : January 6, 2015
Last Update Posted : January 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion||Drug: normal saline Drug: TNK (Tenecteplase)||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||TNK for Loculated Pleural Effusions in Patients With Malignancy|
|Study Start Date :||January 2008|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
Placebo Comparator: Normal Saline
Loculated pleural effusion infused with normal saline twice a day for three days.
Drug: normal saline
Injection of 60 ml normal saline twice a day for three days using the existing chest tube.
Active Comparator: TNKase
Loculated pleural effusion infused with TNK twice a day for three days.
Drug: TNK (Tenecteplase)
Injection of 4 mg of TNK with 59 ml normal saline into the existing chest tube twice a day for three days.
Other Name: TNKase, tenecteplase
- 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
- 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.
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): NCT01580618
|United States, Hawaii|
|Kaiser Foundation Hospital|
|Honolulu, Hawaii, United States, 96819|
|Principal Investigator:||Hyo-Chun Yoon, MD||Kaiser Permanente|