Evidence map›Paper›PMID 34736498›Full record

ArticleTrials2021

The design of a Bayesian adaptive clinical trial of tranexamic acid in severely injured children.

John M VanBuren, T Charles Casper, Daniel K Nishijima, Nathan Kuppermann, Roger J Lewis, J Michael Dean, Anna McGlothlin, TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN)

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.6field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 7 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

John M VanBurenDepartment of Pediatrics, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, 84108, USA. john.vanburen@hsc.utah.edu.ORCID http://orcid.org/0000-0003-1350-5764
T Charles CasperDepartment of Pediatrics, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.
Daniel K NishijimaDepartment of Emergency Medicine, University of California, Davis School of Medicine, Sacramento, CA, 95817, USA.
Nathan KuppermannDepartment of Emergency Medicine, University of California, Davis School of Medicine, Sacramento, CA, 95817, USA.
Roger J LewisDepartment of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, CA, 90509, USA.
J Michael DeanDepartment of Pediatrics, University of Utah School of Medicine, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.
Anna McGlothlinBerry Consultants, LLC, Austin, TX, 78746, USA.
TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN)
University of Utah · USUniversity of California, Davis · USBerry & Associates (United States) · USUCLA Medical Center · US

Funding

Utah Trial Innovation CenterU24TR001597 · NCATS · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2016 to 2022
$39.6M
Enhancing Scientific Inquiry in Clinical Neurosciences Through Methodology TrainiR25NS088248 · NINDS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI COFFEY, CHRISTOPHER S., GUTMANN, LAURIE · 2014 to 2018
$2.3M
Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children (TIC-TOC)R34HL135214 · NHLBI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI KUPPERMANN, NATHAN, NISHIJIMA, DANIEL KIDEN · 2017 to 2018
$751k
NCATS NIH HHS U24 TR001597NCATS NIH HHS U24TR001597NHLBI NIH HHS R34 HL135214NHLBI NIH HHS R34HL135214NINDS NIH HHS R25 NS088248
6 · The paper itself

Abstract

backgroundTrauma is the leading cause of death and disability in children in the USA. Tranexamic acid (TXA) reduces the blood transfusion requirements in adults and children during surgery. Several studies have evaluated TXA in adults with hemorrhagic trauma, but no randomized controlled trials have occurred in children with trauma. We propose a Bayesian adaptive clinical trial to investigate TXA in children with brain and/or torso hemorrhagic trauma. METHODS/

designWe designed a double-blind, Bayesian adaptive clinical trial that will enroll up to 2000 patients. We extend the traditional E DISCUSSION: This trial design evaluating TXA in pediatric hemorrhagic trauma allows for three separate injury populations to be analyzed and compared within a single study framework. Individual conclusions regarding optimal dosing of TXA can be made within each injury group. Identifying the optimal dose of TXA, if any, for various injury types in childhood may reduce death and disability.

Indexed as

Antifibrinolytic AgentsTranexamic AcidWounds and InjuriesAdaptive Clinical Trials as TopicBayes TheoremChildDouble-Blind MethodHemorrhageHumansTrauma Severity IndicesAntifibrinolytic AgentsTranexamic AcidAdaptive clinical trial designBayesian statisticsDose-responsePediatricsResponse-adaptive randomizationTranexamic acidTrauma

Identifiers

PMID34736498
PMCPMC8567588
OpenAlexW3209591820

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.