ABSTRACT
Background
Objectives
Study Design
Results
Conclusions
KEYWORDS
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Publication History
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CONFLICTS OF INTEREST:
Brian Bateman, MD received research funding from grants to his institution from Eli Lilly, Takeda, GlaxoSmithKline, Baxalta, and Pacira outside this study. He is also a consultant to Aetion, Inc and the Alosa Foundation.
Daniela Carusi, MD receives royalties from Wolters Kluwer for UpToDate.
The other authors have no conflicts of interest.
FUNDING SOURCES:
Society for Obstetric Anesthesia and Perinatology (SOAP) Young Investigator Award – No involvement in study design, data collection, analysis, writing of the manuscript, or decision to submit for publication.
Brigham and Women’s Hospital Department Seed Grant – No involvement in study design, data collection, analysis, writing of the manuscript, or decision to submit for publication.
CLINICAL TRIAL REGISTRATION:
i. Date of registration: March 5th, 2019
ii. Date of initial participant enrollment: June 1st, 2019
iii. Clinical trial identification number: NCT03863964
iv. https://clinicaltrials.gov/ct2/show/NCT03863964?term=tranexamic+acid+pharmacokinetics&draw=2&rank=1
v. Data sharing information:
a. Will individual participant data be available? Yes.
b. What data in particular will be shared? All of the individual participant data collected during the trial, after deidentification.
c. What other documents will be available? Study protocol, statistical analysis plan, informed consent form, clinical study report.
d. When will data be available? Immediately following publication. No end date.
e. How will data be shared? Anyone who wishes to access the data can email the corresponding author.
PAPER PRESENTATION INFORMATION:
Some of the findings of this study were presented at the Gertie Marx Competition during the Society for Obstetric Anesthesia and Perinatology 53rd Annual Meeting, held virtually May 13th – May 16th, 2021.
Financial Disclosure/Conflicts of Interest: None
CONDENSATION PAGE
CONDENSATION: Tranexamic acid 1g IV in patients at risk for postpartum hemorrhage resulted in plasma concentrations of >10 μg/mL for at least 60 minutes.
AJOG at a Glance:
A. Why was this study conducted? There is insufficient data on the pharmacokinetics of standard 1g IV dosing of Tranexamic acid (TXA) given to patients at high risk for postpartum hemorrhage (PPH).
B. What are the key findings? TXA 1g IV given during cesarean delivery in patients at high risk for PPH resulted in plasma concentrations of >10 μg/mL for at least 60 minutes.
C. What does this study add to what is already known? This study provides pharmacokinetic guidance for currently accepted TXA dosing regimens and offers direction for future studies to evaluate TXA plasma concentration targets and dosing adjustments.
CONTRIBUTIONS:
Sara M. Seifert, MD: This author helped with the conception of the work, data collection, analysis and interpretation; and helped to draft the manuscript and revise it critically, and approve the final version of the manuscript.
Mario I. Lumbreras-Marquez, MBBS, MMSc: This author helped with the conception of the work, data collection, analysis and interpretation; and helped to draft the manuscript and revise it critically, and approve the final version of the manuscript.
Susan M. Goobie, MD, FRCPC: This author helped with the conception of the work, analysis and interpretation; and helped to draft the manuscript and revise it critically, and approve the final version of the manuscript.
Kara G. Fields, MS: This author helped with the conception of the work, analysis and interpretation; and helped to revise the manuscript critically, and approve the final version of the manuscript.
Daniela A. Carusi, MD, MS: This author helped with the conception of the work, data collection, analysis and interpretation; and helped to draft the manuscript and revise it critically, and approve the final version of the manuscript.
Brian Bateman MD MSc: This author helped with the conception of the work, data collection, analysis and interpretation; and helped to draft the manuscript and revise it critically, and approve the final version of the manuscript.
Michaela K. Farber, MD, MS: This author helped with the conception of the work, data collection, analysis and interpretation; and helped to draft the manuscript and revise it critically, and approve the final version of the manuscript.
