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

NCT00468104 | Completed Results DMC

• 1 other identifier: 11415
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas

Conditions

Pleural Effusion Associated With Pulmonary Infection; Bacterial Pleural Effusion Other Than Tuberculosis

Keywords

parapneumonic pleural effusion; empyema; TPA (Activase, Alteplase)

Outcome Measures

Primary Outcomes (1)

• No Surgical Intervention

  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.

  patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months

Secondary Outcomes (4)

• Number of Participants With Pneumonia That Responded to Therapy

  6 weeks

• Number of Participants With Pleural Effusion/Empyema That Responded to Therapy

  6 weeks

• Number of Participants With Shortness of Breath That Responded to Therapy

  6 weeks

• Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy

  6 weeks

Study Arms (2)

Alteplase, Placebo- intapleural instillation

ACTIVE COMPARATOR

Either 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted.

Drug: Alteplase; Drug: Placebo

Placebo, Alteplase -2nd arm

ACTIVE COMPARATOR

If the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days

Drug: Alteplase; Drug: Placebo

Interventions

Alteplase DRUG

25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days

Alteplase, Placebo- intapleural instillation; Placebo, Alteplase -2nd arm

Placebo DRUG

Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days

Also known as: TPA, Activase

Alteplase, Placebo- intapleural instillation; Placebo, Alteplase -2nd arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with complicated pleural effusions
• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Age \> 18 years

You may not qualify if:

• Current use of oral anticoagulants (e.g., warfarin sodium) with an International Normalized Ratio (INR) \>5- Activated partial thromboplastin time (aPPT) \> 80, Platelet count \< 100,000/mm3;
• Severe uncontrolled hypertension
• Recognized hypersensitivity to Activase; or any component of its formulation; Traumatic pleural effusion
• Pregnancy (positive pregnancy test)
• In another study for this condition
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation
• Recent stroke
• Intracranial hemorrhage
• arteriovenous malformation or aneurysm
• Intracranial neoplasm
• Acute myocardial infarction
• Acute pulmonary embolus

Sponsors & Collaborators

• Midwest Pulmonary and Critical Care: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Conditions

Empyema

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Limitations and Caveats

The sample size for secondary outcomes in the Placebo group is small

Results Point of Contact

• Title: George Thommi
• Organization: Midwest Pulmonary and critical care

tommi4@cox.et

402 206 7372

Study Officials

• George Thommi, MD

  Midwest Pulmonary and Critical Care, PC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 29, 2007
• First Posted: May 2, 2007
• Study Start: April 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: August 1, 2009
• Last Updated: April 30, 2012
• Results First Posted: April 24, 2012

Record last verified: 2012-04

Locations

US (1)