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Trials. 2017 Jun 24;18(1):293. doi: 10.1186/s13063-017-2026-0.

Intrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized controlled trial.

Author information

1
McMaster Children's Hospital, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
2
The Hospital for Sick Children, Department of Pediatrics, University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.
3
Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, ON, M5T 3M7, Canada.
4
Applied Health Research Centre of the Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.
5
Children's Hospital of Eastern Ontario, University of Ottawa, 401 Smyth Road, Ottawa, ON, K1H 5B2, Canada.
6
Centre Hospitalier Universitaire Sainte-Justine, Université de Montréal, 3175 Chemin de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.
7
Department of Pediatrics, Division of Respiratory Medicine, British Columbia's Children's Hospital, University of British Columbia, 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada.
8
Alberta Children's Hospital, University of Calgary, 2888 Shaganappi Trail NW, Calgary, AB, T3B 6A9, Canada.
9
The Hospital for Sick Children, Department of Pediatrics, University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada. eyal.cohen@sickkids.ca.

Abstract

BACKGROUND:

A randomized controlled trial of adults with empyema recently demonstrated decreased length of stay in hospital in patients treated with intrapleurally administered dornase alfa and fibrinolytics compared to fibrinolytics alone. Whether this treatment strategy is safe and effective in children remains unknown.

METHODS/DESIGN:

This study protocol is for a superiority, placebo-controlled, parallel-design, multicenter randomized controlled trial. The participants are previously well children admitted to a children's hospital with a diagnosis of empyema requiring chest tube insertion and fibrinolytics administered intrapleurally. Children will be randomized after the treating physician has decided that pleural drainage is required but prior to chest tube insertion. After chest tube insertion, participants in the treatment group will receive intrapleurally administered tissue plasminogen activator (tPA) 4 mg followed by dornase alfa 5 mg. Participants in the placebo group will receive tPA 4 mg followed by normal saline. Study treatments will be administered once daily for 3 days. All participants, parents or caregivers, clinicians, and research personnel will remain blinded. The primary outcome is length of stay from chest tube insertion to discharge from hospital. Secondary outcomes include time to meeting discharge criteria, chest tube duration, fever duration, need for additional procedures, adverse events, hospital readmission, cost of hospitalization, and mortality.

DISCUSSION:

This multicenter randomized controlled trial will assess the safety, effectiveness, and cost-effectiveness of combined treatment with dornase alfa and fibrinolytics compared to fibrinolytics alone for the treatment of empyema in children.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT01717742 . Registered on 8 October 2012.

KEYWORDS:

Chest tubes; Children; Empyema; Fibrinolytic agents; Randomized controlled trial

PMID:
28646887
PMCID:
PMC5482972
DOI:
10.1186/s13063-017-2026-0
[Indexed for MEDLINE]
Free PMC Article

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