Trial Outcomes & Findings for Tenecteplase (TNK) for Loculated Pleural Effusions in Patients With Malignancy (NCT NCT01580618)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

20 participants

Primary outcome timeframe

3-5 days

Results posted on

2015-01-06

Participant Flow

All patients were hospitalized patients with symptomatic loculated effusions. Each patient had a chest tube placed and loculated nature of the effusion confirmed by chest xray or CT after initial drainage of fluid from the chest tube.

Once loculation was documented, each patient was randomized to receive either normal saline or TNKase administered through the chest tube on a twice a day regimen for 3 days. For those in the TNKase group, each patient received 4mg TNKase in 60 mL normal saline twice daily. The normal saline group, each patient received 60mL normal saline.

Participant milestones

Participant milestones
Measure	Normal Saline Loculated pleural effusion infused with normal saline twice a day for three days.	TNKase Loculated pleural effusion infused with TNK twice a day for three days.
Overall Study STARTED	8	12
Overall Study COMPLETED	7	12
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Saline n=8 Participants Loculated pleural effusion infused with normal saline twice a day for three days.	TNKase n=12 Participants Loculated pleural effusion infused with TNK twice a day for three days.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	70 years STANDARD_DEVIATION 11 • n=5 Participants	62 years STANDARD_DEVIATION 12 • n=7 Participants	66 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	12 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 3-5 days

Outcome measures

Outcome measures
Measure	Normal Saline n=8 Participants Loculated pleural effusion infused with normal saline twice a day for three days.	TNKase n=12 Participants Loculated pleural effusion infused with TNK twice a day for three days.
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.	12.5 percentage of participants	75 percentage of participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Normal Saline n=8 Participants Loculated pleural effusion infused with normal saline twice a day for three days.	TNKase n=12 Participants Loculated pleural effusion infused with TNK twice a day for three days.
Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage	12.5 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Normal Saline n=1 Participants Loculated pleural effusion infused with normal saline twice a day for three days.	TNKase Loculated pleural effusion infused with TNK twice a day for three days.
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.	0 percentage of participants	—

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Normal Saline n=8 Participants Loculated pleural effusion infused with normal saline twice a day for three days.	TNKase n=12 Participants Loculated pleural effusion infused with TNK twice a day for three days.
Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion.	25 percentage of participants	92 percentage of participants

SECONDARY outcome

Timeframe: 30 days

This measures the number of hospital days for each participant after they were started on their infusion therapy.

Outcome measures

Outcome measures
Measure	Normal Saline n=8 Participants Loculated pleural effusion infused with normal saline twice a day for three days.	TNKase n=12 Participants Loculated pleural effusion infused with TNK twice a day for three days.
Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion	13.4 days Standard Deviation 6.8	10.9 days Standard Deviation 4.5

Adverse Events

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TNKase

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Normal Saline n=7 participants at risk Loculated pleural effusion infused with normal saline twice a day for three days.	TNKase n=13 participants at risk Loculated pleural effusion infused with TNK twice a day for three days.
Respiratory, thoracic and mediastinal disorders intrapleural hemorrhage	0.00% 0/7 • From time of randomization until the time of pleural catheter removal. Intrapleural hemorrhage was the specific adverse event which can be directly related to the presence of a chest tube and/or infusion of fluid into the pleural space.	7.7% 1/13 • Number of events 1 • From time of randomization until the time of pleural catheter removal. Intrapleural hemorrhage was the specific adverse event which can be directly related to the presence of a chest tube and/or infusion of fluid into the pleural space.

Other adverse events

Adverse event data not reported

Additional Information

Hyo-Chun Yoon, MD, PHD

Kaiser Permanente

Phone: 8084327342

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place