Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries Article Swipe
Seth W. Linakis
,
Nathan Kuppermann
,
Rachel Stanley
,
Hilary A. Hewes
,
Sage R. Myers
,
John M. VanBuren
,
T. Charles Casper
,
Matthew Bobinski
,
Simona Ghetti
,
Walton O. Schalick
,
Daniel K. Nishijima
·
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.1111/acem.14343
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.1111/acem.14343
Background Federal 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. Methods We 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. Results We 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. Conclusions In 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.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1111/acem.14343
- https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/acem.14343
- OA Status
- bronze
- Cited By
- 3
- References
- 15
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3179118445
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W3179118445Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1111/acem.14343Digital Object Identifier
- Title
-
Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuriesWork title
- Type
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articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2021Year of publication
- Publication date
-
2021-07-12Full publication date if available
- Authors
-
Seth W. Linakis, Nathan Kuppermann, Rachel Stanley, Hilary A. Hewes, Sage R. Myers, John M. VanBuren, T. Charles Casper, Matthew Bobinski, Simona Ghetti, Walton O. Schalick, Daniel K. NishijimaList of authors in order
- Landing page
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https://doi.org/10.1111/acem.14343Publisher landing page
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/acem.14343Direct link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
-
bronzeOpen access status per OpenAlex
- OA URL
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/acem.14343Direct OA link when available
- Concepts
-
Medicine, Tranexamic acid, Informed consent, Randomization, Randomized controlled trial, Institutional review board, Clinical trial, Emergency medicine, Surgery, Internal medicine, Alternative medicine, Pathology, Blood lossTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
3Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 1, 2024: 1, 2022: 1Per-year citation counts (last 5 years)
- References (count)
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15Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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