Trial · NCT00468104

Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas

NCT00468104, Not applicable, Completed, Midwest Pulmonary and Critical Care; results first posted 2012-04-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas. Trials, record NCT00468104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00468104

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas
NCT number: NCT00468104
Status: Completed
Phases: Not applicable
Enrollment: 100 participants, actual
Lead sponsor: Midwest Pulmonary and Critical Care
Conditions: Pleural Effusion Associated With Pulmonary Infection, Bacterial Pleural Effusion Other Than Tuberculosis
Interventions: Alteplase, Placebo
First posted: 2007-05-02
Last updated: 2012-04-30
Results first posted: 2012-04-24
Limitations and caveats: The sample size for secondary outcomes in the Placebo group is small

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	No Surgical Intervention	patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months	CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.
Secondary	Number of Participants With Pneumonia That Responded to Therapy	6 weeks	patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pneumonia
Secondary	Number of Participants With Pleural Effusion/Empyema That Responded to Therapy	6 weeks	patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pleural effusion/empyema
Secondary	Number of Participants With Shortness of Breath That Responded to Therapy	6 weeks	patients were followed for 6 weeks and clinical symptoms of resolution of shortness of breath were documented
Secondary	Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy	6 weeks	patients were followed for 6 weeks and resolution of sepsis was documented

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	No Surgical Intervention	patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months	intention to treat	participants	NUMBER
SECONDARY	Number of Participants With Pneumonia That Responded to Therapy	6 weeks	protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed	participants	NUMBER
SECONDARY	Number of Participants With Pleural Effusion/Empyema That Responded to Therapy	6 weeks	protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed	participants	NUMBER
SECONDARY	Number of Participants With Shortness of Breath That Responded to Therapy	6 weeks	protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed	participants	NUMBER
SECONDARY	Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy	6 weeks	protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed	participants	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
No Surgical Intervention	Alteplase		66		participants
No Surgical Intervention	Placebo		6		participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention	STARTED	Alteplase Then Placebo	54
First Intervention	STARTED	Placebo Then Alteplase	46
First Intervention	COMPLETED	Alteplase Then Placebo	45
First Intervention	COMPLETED	Placebo Then Alteplase	45
First Intervention	NOT COMPLETED	Alteplase Then Placebo	9
First Intervention	NOT COMPLETED	Placebo Then Alteplase	1
Second Intervention	STARTED	Alteplase Then Placebo	8
Second Intervention	STARTED	Placebo Then Alteplase	41
Second Intervention	COMPLETED	Alteplase Then Placebo	3
Second Intervention	COMPLETED	Placebo Then Alteplase	37

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events24

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
other	severe chest pain post drug instillation	General disorders	Received Alteplase Only	1	42	12
other	severe chest pain post drug instillation	General disorders	Received Placebo Only	0	8	12
other	severe chest pain post drug instillation	General disorders	Received Both Alteplase and Placebo	1	40	12
other	mild to moderate chest pain	General disorders	Received Alteplase Only	6	42	12
other	mild to moderate chest pain	General disorders	Received Placebo Only	1	8	12
other	mild to moderate chest pain	General disorders	Received Both Alteplase and Placebo	3	40	12
other	hypotension and worsening renal function	General disorders	Received Alteplase Only	0	42	4
other	hypotension and worsening renal function	General disorders	Received Placebo Only	0	8	4
other	hypotension and worsening renal function	General disorders	Received Both Alteplase and Placebo	4	40	4
other	blood loss--pleural fluid	Blood and lymphatic system disorders	Received Alteplase Only	3	42	3

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Received Alteplase Only
Total, all-cause mortality	Received Placebo Only
Total, all-cause mortality	Received Both Alteplase and Placebo
Total, other adverse events	Received Alteplase Only	10	42
Total, other adverse events	Received Placebo Only	5	8
Total, other adverse events	Received Both Alteplase and Placebo	8	40
Total, serious adverse events	Received Alteplase Only	1	42
Total, serious adverse events	Received Placebo Only	0	8
Total, serious adverse events	Received Both Alteplase and Placebo	0	40

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
Alteplase vs Placebo: No Surgical Intervention

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00468104

GET https://conductscience.org/api/trials/v1/NCT00468104/events?page=2

API reference For AI assistants