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Trial · NCT01717742

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime to Hospital Dischargeup to 4 monthsTime from insertion of the chest drain to discharge from hospital.
SecondaryTime to Meeting Discharge Criteriaup to 4 months
Time from insertion of the chest drain to meeting discharge criteria. Discharge criteria: * Chest tube removed * No fever \[temperature less than 38°C\] * Normal respiratory rate forage * No hypoxia * Drinking fluids wel
SecondaryTime to Drain Removalup to 4 monthsTime from drain insertion to drain removal.
SecondaryDuration of Fever After Interventionup to 4 monthsDuration of fever (defined as temperature \>38 degrees celsius taken by any method) from insertion of the chest drain until resolution.
SecondaryNumber of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Interventionup to 4 monthsNumber of Participants with need for any kind of ventilatory support or any kind of non-invasive ventilation right after the intervention.
SecondaryNumber of Participants With Serious Bleedingup to 4 monthsNumber of Participants who had intrapleural bleeding resulting in a drop in hemoglobin of greater than 20 g/L or needing a transfusion.
SecondaryNumber of Participants With Further Interventionsup to 4 months
Number of participants who needed further intervention such as placement of another chest drain (by any technique) or surgical intervention such as thoracotomy and decortication, video-assisted thorascopic surgery, or pneumonectomy.
SecondaryNumber of Participants With Hospital Readmission3 months post-dischargeNumber of Participants who had any hospital readmission after discharge from hospital for initial treatment for pleural empyema within three months related to pleural empyema or its treatment.
SecondaryCost of the Hospitalizationup to 4 monthsAn economic evaluation will compare the relative costs of DNase-tPA with tPA alone in previously well children who present with pleural empyema, using patient-level data from the trial.
SecondaryMortalityup to 4 monthsMortality from any cause during the hospitalization for empyema.
OtherChest Radiography7 days after drain removal
The radiograph closest to the time of drain removal will be reviewed by a blinded study radiologist to determine the percentage of hemithorax occupied using a 5 point ordinal scale utilized in previous studies ranging from no fluid present to fluid occupying \>75% of the most affected hemithorax.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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