NCT03716375

Brief Summary

Intrapleural administration of fibrinolytic therapy, urokinase in parapneumonic effusion and empyema has been shown to decrease the need for surgical intervention and length of hospital stay. Pleural adhesions are easily formed in the early stages of empyema and the thickening of the pleural causes subsequent treatment difficulties. The goal of this study was to observe and compare the efficacy of treatment in empyema patients with urokinase and chest drainage or with chest drainage or with chest tube drainage alone so as to provide evidence for guiding clinical treatment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

November 6, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

October 7, 2018

Last Update Submit

November 5, 2018

Conditions

Complicated Pleural Effusion/ Empyema

Keywords

Pleural empyema, urokinase

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    2 weeks

Secondary Outcomes (4)

  • Days of fever after chest tube insertion

    3 to 4 days

  • Duration of drainage

    2 weeks

  • Complications

    2weeks

  • Failure rate

    2weeks

Study Arms (2)

use of fibrinolytic agent

EXPERIMENTAL

Chest tube drainage with intrapleural urokinase instillation 1000 IU/ml

Drug: Intrapleural Medications

no use of any drug

NO INTERVENTION

Chest tube drainage

Interventions

Intrapleural MedicationsDRUG

urokinase

use of fibrinolytic agent

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Previously healthy child with age between 1 month to 18 years
  • Admitted with diagnosis of Pleural empyema requiring chest tube insertion and fibrinolytics (as judged by the attending physician) with the following criteria:
  • I. Pneumonia with pleural empyema based on chest ultrasound and CT scan. II. Need for further intervention based on clinical criteria (persistent fever despite antibiotics for at least 48 hours, significant respiratory distress, tachypnea or hypoxia as a result of pleural empyema.

You may not qualify if:

  • Subject will be excluded if she or he has one of the followings:
  • Empyema as result of tuberculosis, fungus or noninfectious causes (e.g. malignancy)
  • Known coagulation impairment
  • Suspected allergy to urokinase
  • Child has already undergone drainage procedure or drug was used in 30 days (e.g.
  • chest tube or VATS
  • Chronic lung diseases or other chronic illnesses (e.g. Immunodeficiency, neurological impairment possible)
  • Significant thoracic trauma in last 2 months
  • Severe arterial hypertension
  • Presence of Pneumothorax before treatment (i.e. bronchopleural fistula)
  • Pregnancy
  • Breast feeding
  • Poor compliance
  • Contraindication in the presence of fibrinolytic agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Shirota C, Uchida H. Initial treatment of septated parapneumonic empyema with drainage plus fibrinolytic agents is equally effective as video-assisted thoracoscopic surgery, and is suitable as first-line therapy. Transl Pediatr. 2015 Jan;4(1):41-4. doi: 10.3978/j.issn.2224-4336.2015.02.01.

    PMID: 26835359RESULT

  • Stefanutti G, Ghirardo V, Barbato A, Gamba P. Evaluation of a pediatric protocol of intrapleural urokinase for pleural empyema: a prospective study. Surgery. 2010 Sep;148(3):589-94. doi: 10.1016/j.surg.2010.01.010. Epub 2010 Mar 20.

    PMID: 20304453RESULT

  • Walker W, Wheeler R, Legg J. Update on the causes, investigation and management of empyema in childhood. Arch Dis Child. 2011 May;96(5):482-8. doi: 10.1136/adc.2009.165357. Epub 2010 Aug 24.

    PMID: 20736395RESULT

MeSH Terms

Conditions

Empyema, Pleural

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsEmpyemaSuppurationPleural DiseasesRespiratory Tract DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xu Baoping, MD, PhD

    Beijings Children´s Hospital of Capital Medical University, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Baoping, MD, PhD

CONTACT

+861059616308xubaopingbch@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Respiratory Department

Study Record Dates

First Submitted

October 7, 2018

First Posted

October 23, 2018

Study Start

November 1, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2020

Last Updated

November 6, 2018

Record last verified: 2018-10