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Status unknownNCT02165891UROVATSUpdated Jul 5, 2018

Comparison of Intrapleural Urokinase and Video-Assisted Thorascopic Surgery in the Treatment of Parapneumonic Pleural Effusion in Children

A Phase 3 interventional study of insertion of a chest drain with urokinase instillation and primary video-assisted thorascopic surgery in Empyema, Pleural, sponsored by Queen Fabiola Children's University Hospital. Status unknown at 1 site in Belgium. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2018-07-05.

Sponsored by Queen Fabiola Children's University Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
1 Year to 16 Years
Sex
All
01

Study summary

Despite the improvement in the technology available for diagnosing and treating empyema, the management of empyema in children remains controversial.

The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema.

02

Conditions studied

  • Empyema, Pleural

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03

In context

Empyema, Pleural

33 studies on the registry are indexed under Empyema, Pleural; 11 are open to participants now.

This study's planned enrollment of 40 is below the median of 77 across 26 interventional studies indexed under Empyema, Pleural.

Browse Empyema, Pleural studies →

Lead sponsor

Queen Fabiola Children's University Hospital is the lead sponsor of 28 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients under the age of 17
  • pleural fluid depth of at least 15mm, confirmed by ultrasound

  • at least one of the following severity criteria :

    1. fever continuing 48h after starting correct antibiotherapy
    2. respiratory distress
    3. mediastinal displacement on the chest X-ray

Exclusion criteria

Exclusion Criteria:

  • previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain associated with urokinase- congenital pulmonary disorders with lung function impairment
  • congenital pulmonary disorders with lung function impairment
  • chronic pulmonary disease associated with lung function impairment
  • hemodynamic instability
  • congenital immunodeficiency disease
  • secondary immune deficiency induced
  • hemostasis disorder ( of thrombolytic therapy)
  • pregnancy or breastfeeding patient
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Other
    Urokinase

    insertion of a chest drain with urokinase instillation

    Drug: insertion of a chest drain with urokinase instillation

  • Other
    VATS

    primary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms

    Procedure: primary video-assisted thorascopic surgery

Interventions

  • Druginsertion of a chest drain with urokinase instillation

    Other interventions except drainage procedure are the same in both arms

  • Procedureprimary video-assisted thorascopic surgery
06

What researchers measure

Primary outcomes

  1. duration of drainage

    Time frame: end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days

Secondary outcomes

  1. length of hospital stay

    Time frame: Hospital departure with an expected average time of two weeks to one month

  2. Duration of oxygen therapy

    Time frame: up to the end of patient hospitalisation with an expected average time of 48 hours to five days

  3. duration of intravenous antibiotic therapy

    Time frame: up to the last intravenous antibiotic injection, minimum of 48 hours for a simple pleural effusion and a minimum of 14 days for an empyema with a maximum of one month

  4. Duration of fever > 38.5°C

    Time frame: Up to fever resolution, with an average expected time of five days to 14 days

  5. Number of Participants with Serious and Non-Serious Adverse Events

    Time frame: Up to the end of the hospitalisation, until three months corresponding to the end of follow up period

  6. Patient discomfort

    Time frame: Up to chest drain removal with an average expected time of 48 hours up to seven days

07

Study locations

1 of 1 sites recruiting
  • Queen Fabiola University Children Hospital
    Brussels, 1020, Belgium
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2015, a primary completion of Jun 2020 and a completion of Jun 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2014
First posted
Jun 18, 2014
Start
Feb 2015
Primary completionEst.
Jun 2020
CompletionEst.
Jun 2020
Last update
Jul 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02165891
Lead sponsor
Queen Fabiola Children's University Hospital
Responsible party
Sponsor
First posted
Jun 18, 2014
Start date
Feb 2015
Primary completion
Jun 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
Jul 5, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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