Trial · NCT01580618
Tenecteplase (TNK) for Loculated Pleural Effusions in Patients With Malignancy
NCT01580618, Phase 2, Phase 3, Terminated, Kaiser Permanente; results first posted 2015-01-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tenecteplase (TNK) for Loculated Pleural Effusions in Patients With Malignancy. Trials, record NCT01580618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01580618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tenecteplase (TNK) for Loculated Pleural Effusions in Patients With Malignancy
- NCT number
- NCT01580618
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 20 participants, actual
- Lead sponsor
- Kaiser Permanente
- Conditions
- Pleural Effusion
- Interventions
- normal saline, TNK (Tenecteplase)
- First posted
- 2012-04-19
- Last updated
- 2026-04-14
- Results first posted
- 2015-01-06
- Limitations and caveats
- Results are limited due to the small numbers of patients enrolled
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 3-5 days | |
| Primary | Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage | 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 |
| Secondary | 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. | 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. |
| Secondary | Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion. | 30 days | |
| Secondary | Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion | 30 days | This measures the number of hospital days for each participant after they were started on their infusion therapy. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | 3-5 days | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage | 3-5 days | percentage of participants | NUMBER | |
| SECONDARY | 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. | 3-5 days | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion. | 30 days | percentage of participants | NUMBER | |
| SECONDARY | Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion | 30 days | days | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Normal Saline | 12.5 | percentage of participants | ||
| 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. | TNKase | 75 | percentage of participants | ||
| Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage | Normal Saline | 12.5 | percentage of participants | ||
| Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage | TNKase | 0 | percentage of participants | ||
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. | Normal Saline | 0 | percentage of participants | ||
| Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion. | Normal Saline | 25 | percentage of participants | ||
| Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion. | TNKase | 92 | percentage of participants | ||
| Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion | Normal Saline | 13.4 | Standard Deviation 6.8 | days | |
| Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion | TNKase | 10.9 | Standard Deviation 4.5 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Normal Saline | 8 | |
| Overall Study | STARTED | TNKase | 12 | |
| Overall Study | COMPLETED | Normal Saline | 7 | |
| Overall Study | COMPLETED | TNKase | 12 | |
| Overall Study | NOT COMPLETED | Normal Saline | 1 | |
| Overall Study | NOT COMPLETED | TNKase | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | intrapleural hemorrhage | Respiratory, thoracic and mediastinal disorders | Normal Saline | 0 | 7 | 0 |
| serious | intrapleural hemorrhage | Respiratory, thoracic and mediastinal disorders | TNKase | 1 | 13 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Normal Saline | ||
| Total, all-cause mortality | TNKase | ||
| Total, other adverse events | Normal Saline | 0 | 7 |
| Total, other adverse events | TNKase | 0 | 13 |
| Total, serious adverse events | Normal Saline | 0 | 7 |
| Total, serious adverse events | TNKase | 1 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Normal Saline vs TNKase: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01580618
GET https://conductscience.org/api/trials/v1/NCT01580618/registered