Urokinase Versus Primary Video-Assisted Thorascopic Surge... | NCT00144950

Studies
Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema

NCT00144950

Sponsor

Institute of Child Health

Status

Completed

Last Update Posted

Sep 5, 2005Estimated

Enrollment

Phase

Phase 1

Conditions

Empyema

Interventions

insertion of a chest drain with urokinase instillation
primary video-assisted thorascopic surgery

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2005

Last Update Posted Date

Sep 5, 2005Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
length of hospital stay

Measure	Description	Time Frame
radiological changes at follow up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients under the age of 16 referred to GOSH for management of empyema

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam Jaffe, Dr	Great Ormond Street Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Great Ormond Street Hospital		London			United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18492739	Derived	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.

ID	Term
D013492	Suppuration
D007239	Infections
D007249	Inflammation
D010335	Pathologic Processes

Name	Type	Description	Arm Group Labels	Other Names
insertion of a chest drain with urokinase instillation	Drug
primary video-assisted thorascopic surgery	Procedure