Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Empyema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

1. Objectives:

* Main objective: To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema.
* To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase
* To evaluate the safety of alteplase in the treatment of complex complicated parapneumonic pleural effusion and empyema
2. Design: Multicentric, randomized, parallel, controlled and double blind
3. Main variable: Percentage of curation
4. Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema
5. Duration of the treatment: Three days (main variable), and optional three days (secondary variable)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00468104

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

COMPLETED NA

Efficacy of Fibrinolytic Agents in Complicated Pleural Effusion

NCT03716375

Complicated Pleural Effusion/ Empyema

UNKNOWN NA

Intrapleural Urokinase for Retained Hemothorax

NCT01134237

Retained Hemothorax

UNKNOWN PHASE3

Pleural Irrigation With Normal Saline Versus Intrapleural Fibrinolytic

NCT05903417

Pleural Infection

UNKNOWN NA

Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion

NCT06184321

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Empyema, Pleural Pleural Effusion Pleural Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

urokinase

Group Type ACTIVE_COMPARATOR

Intrapleurally Alteplase vs Intrapleurally Urokinase

Intervention Type DRUG

Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days

Alteplase

Group Type ACTIVE_COMPARATOR

Intrapleurally Alteplase vs Intrapleurally Urokinase

Intervention Type DRUG

Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intrapleurally Alteplase vs Intrapleurally Urokinase

Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Empyema and Complex Complicated Parapneumonic Pleural Effusion

Exclusion Criteria

* Pregnancy or breastfeeding
* Critically illness
* Systemic anticoagulant treatment
* Coagulation Disorder
* Bronchopleural fistula
* Active bleeding
* Recent punction of noncompressive artery
* Stroke in the last 6 months
* Major intervention o major traumatism in the last 6 weeks
* Hypersensibility to urokinase or alteplase
* Severe Liver or kidney failure
* Inclusion in another interventional study in the last month

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No