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

Simple item page
dc.contributor.authorLivingston, Michael H
dc.contributor.authorMahant, Sanjay
dc.contributor.authorRatjen, Felix
dc.contributor.authorConnolly, Bairbre L
dc.contributor.authorThorpe, Kevin
dc.contributor.authorMamdani, Muhammad
dc.contributor.authorMaclusky, Ian
dc.contributor.authorLaberge, Sophie
dc.contributor.authorGiglia, Lucy
dc.contributor.authorWalton, J. M
dc.contributor.authorYang, Connie L
dc.contributor.authorRoberts, Ashley
dc.contributor.authorShawyer, Anna C
dc.contributor.authorBrindle, Mary
dc.contributor.authorParsons, Simon J
dc.contributor.authorStoian, Cristina A
dc.contributor.authorCohen, Eyal
dc.date.accessioned2018-11-07T17:03:18Z
dc.date.available2018-11-07T17:03:18Z
dc.date.issued2017-06-24
dc.date.updated2018-11-07T17:03:18Z
dc.description.abstractAbstract 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.
dc.identifier.citationTrials. 2017 Jun 24;18(1):293
dc.identifier.doihttps://doi.org/10.1186/s13063-017-2026-0
dc.identifier.urihttp://hdl.handle.net/1880/108990
dc.language.rfc3066en
dc.rights.holderThe Author(s).
dc.titleIntrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized controlled trial
dc.typeJournal Article
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
13063_2017_Article_2026.pdf
Size:
960.5 KB
Format:
Adobe Portable Document Format
Description:
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
0 B
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Open Access Publications