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Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema

Primary Purpose

Empyema

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

insertion of a chest drain with urokinase instillation

primary video-assisted thorascopic surgery

About this trial

This is an interventional treatment trial for Empyema

Eligibility Criteria

0 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients under the age of 16 referred to GOSH for management of empyema Exclusion Criteria: -

Sites / Locations

Great Ormond Street Hospital

Outcomes

Primary Outcome Measures

length of hospital stay

Secondary Outcome Measures

radiological changes at follow up

Full Information

NCT ID

NCT00144950

First Posted

September 2, 2005

Last Updated

September 2, 2005

Sponsor

Institute of Child Health

1. Study Identification

Unique Protocol Identification Number

NCT00144950

Brief Title

Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Institute of Child Health

4. Oversight

5. Study Description

Brief Summary

This study will compare VATS versus chest drain insertion and urokinase in the treatment of childhood empema by a randomised prospective study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Empyema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

insertion of a chest drain with urokinase instillation

Intervention Type

Procedure

Intervention Name(s)

primary video-assisted thorascopic surgery

Primary Outcome Measure Information:

Title

length of hospital stay

Secondary Outcome Measure Information:

Title

radiological changes at follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients under the age of 16 referred to GOSH for management of empyema Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Jaffe, Dr

Organizational Affiliation

Great Ormond Street Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Great Ormond Street Hospital

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

18492739

Citation

Jaffe A, Calder AD, Owens CM, Stanojevic S, Sonnappa S. Role of routine computed tomography in paediatric pleural empyema. Thorax. 2008 Oct;63(10):897-902. doi: 10.1136/thx.2007.094250. Epub 2008 May 20.

Results Reference

derived

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Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema

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