Evidence map›Paper›PMID 34250690›Full record

Trial reportAcademic emergency medicine : official journal of the Society for Academic Emergency Medicine2021

Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries.

Seth W Linakis, Nathan Kuppermann, Rachel M Stanley, Hilary Hewes, Sage Myers, John M VanBuren, T Charles Casper, Matthew Bobinski, Simona Ghetti, Walton O Schalick and 2 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): A pilot randomized trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2022
    Article
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

12 authors.

Seth W LinakisDivision of Pediatric Emergency Medicine, Nationwide Children's Hospital, Columbus, Ohio, USA.ORCID 0000-0002-8527-2042
Nathan KuppermannDepartment of Emergency Medicine, University of California at Davis School of Medicine, Sacramento, California, USA.
Rachel M StanleyDivision of Pediatric Emergency Medicine, Nationwide Children's Hospital, Columbus, Ohio, USA.
Hilary HewesDepartment of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Sage MyersDivision of Emergency Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
John M VanBurenDepartment of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA.
T Charles CasperDepartment of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Matthew BobinskiDepartment of Emergency Medicine, University of California at Davis School of Medicine, Sacramento, California, USA.
Simona GhettiDepartment of Psychology, University of California at Davis, Davis, California, USA.
Walton O SchalickDepartment of Orthopedics and Rehabilitation, University of Wisconsin, Madison, Wisconsin, USA.
Daniel K NishijimaDepartment of Pediatrics, The Ohio State University, Columbus, Ohio, USA.ORCID 0000-0003-4952-8212
TIC-TOC Collaborators of the Pediatric Emergency Care Applied Research Network (PECARN)

Funding

Utah Trial Innovation CenterU24TR001597 · NCATS · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2016 to 2022
$39.6M
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
HRSA HHS U03MC00001HRSA HHS U03MC00003HRSA HHS U03MC00006HRSA HHS U03MC00007HRSA HHS U03MC00008HRSA HHS U03MC22684HRSA HHS U03MC22685NCATS NIH HHS U24 TR001597NHLBI NIH HHS R34 HL135214
6 · The paper itself

Abstract

backgroundFederal exception from informed consent (EFIC) procedures allow studies to enroll patients with time-sensitive, life-threatening conditions when written consent is not feasible. Our objective was to compare enrollment rates with and without EFIC in a trial of tranexamic acid (TXA) for children with hemorrhagic injuries.

methodsWe conducted a four-center randomized controlled pilot and feasibility trial evaluating TXA in children with severe hemorrhagic brain and/or torso injuries. We initiated the trial enrolling patients without EFIC. After 3 months of enrollment, we met our a priori futility threshold and paused the trial to incorporate EFIC procedures and obtain regulatory approval. We then restarted the trial allowing EFIC if the guardian was unable to provide timely written consent. We used descriptive statistics to compare characteristics of eligible patients approached with and without EFIC procedures. We also calculated the time delay to restart the trial using EFIC.

resultsWe enrolled one of 15 (6.7%) eligible patients (0.17 per site per month) prior to using EFIC procedures. Of the 14 missed eligible patients, seven (50%) were not enrolled because guardians were not present or were injured and unable to provide written consent. After obtaining approval for EFIC, we enrolled 30 of 48 (62.5%) eligible patients (1.34 per site per month). Of these 30 patients, 22 (73.3%) were enrolled with EFIC. Of the 22, no guardians refused written consent after randomization. There were no significant differences in the eligibility rate and patient characteristics enrolled with and without EFIC procedures. Across all sites, the mean delay to restart the trial using EFIC procedures was 12 months.

conclusionsIn a multicenter trial of severely injured children, the use of EFIC procedures greatly increased the enrollment rate and was well accepted by guardians. Initiating the trial without EFIC procedures led to a significant delay in enrollment.

Indexed as

Tranexamic AcidChildHemorrhageHumansInformed ConsentPilot ProjectsTranexamic Acidexception from informed consent (EFIC)pediatric traumatranexamic acid

Identifiers

PMID34250690
PMCPMC8712344

What OpenQuestion holds

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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.