Evidence map›Paper›PMID 33576009›Full record

ArticleBritish journal of clinical pharmacology2021

Population pharmacokinetics and pharmacodynamics of Tranexamic acid in women undergoing caesarean delivery.

Shuhui Li, Homa K Ahmadzia, Dong Guo, Elyes Dahmane, Adam Miszta, Naomi L C Luban, Jeffrey S Berger, Andra H James, Alisa S Wolberg, John N van den Anker and 1 more

Open access · bronzeAbstract read
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Article in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
6.7field-weighted citation impact, top 3% 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

18 citing papers in PubMed, 29 citations in OpenAlex.

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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

11 authors at 5 institutions in 3 countries.

Shuhui LiCenter for Translational Medicine, School of Pharmacy, University of Maryland, Baltimore, M.D., USA.ORCID 0000-0002-5200-4754
Homa K AhmadziaDivision of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, The George Washington University School of Medicine and Health Sciences, Washington, D.C., USA.
Dong GuoSchool of Pharmacy, University of Maryland, Baltimore, M.D., USA.
Elyes DahmaneCenter for Translational Medicine, School of Pharmacy, University of Maryland, Baltimore, M.D., USA.
Adam MisztaDepartment of Pathology and Laboratory Medicine and UNC Blood Research Center, University of North Carolina, Chapel Hill, N.C., USA.
Naomi L C LubanDivision of Hematology, Children's National Hospital, Washington, D.C., USA.
Jeffrey S BergerDepartment of Anesthesiology and Critical Care Medicine, The George Washington University School of Medicine and Health Sciences, Washington, D.C., USA.
Andra H JamesDivision of Maternal-Fetal Medicine, Department of Obstetrics & Gynecology, Duke University, Durham, N.C., USA.
Alisa S WolbergDepartment of Pathology and Laboratory Medicine and UNC Blood Research Center, University of North Carolina, Chapel Hill, N.C., USA.
John N van den AnkerDivision of Clinical Pharmacology, Children's National Hospital, Washington, D.C., USA.
Jogarao V S GobburuCenter for Translational Medicine, School of Pharmacy, University of Maryland, Baltimore, M.D., USA.ORCID 0000-0002-8348-4295
University of Maryland, Baltimore · USChildren's National · USGeorge Washington University · USUniversity of North Carolina at Chapel Hill · USDuke University · US

Funding

Clinical and Translational Science Institute at Childrens NationalUL1TR001876 · NCATS · CHILDREN'S RESEARCH INSTITUTE · PI BELL, MICHAEL J · 2016 to 2021
$25.6M
Fibrinogen and Factor XIII in Venous ThrombosisR01HL126974 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Alisa S. Wolberg · 2016 to 2026
$4.4M
Targeting the Plasminogen Activation System to Limit Pancreatic Cancer Progression and Associated ThrombosisU01HL143403 · NHLBI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FISHEL, MELISSA L., FLICK, MATTHEW J. · 2018 to 2022
$4.2M
Model system of oral contraceptive-induced VTE: integrating genomic, transcriptomic, and proteomic discovery with functional biologyR33HL141791 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI LOWENSTEIN, CHARLES J, SMITH, NICHOLAS L · 2020 to 2022
$2.0M
Clinical and Translational Science Institute at Childrens National-Mentored Career Development CoreKL2TR001877 · NCATS · CHILDREN'S RESEARCH INSTITUTE · PI LUBAN, NAOMI L · 2016 to 2020
$2.0M
Model system of oral contraceptive-induced VTE: integrating genomic, transcriptomic, and proteomic discovery with functional biologyR61HL141791 · NHLBI · UNIVERSITY OF ROCHESTER · PI LOWENSTEIN, CHARLES J, SMITH, NICHOLAS L · 2018 to 2019
$1.4M
Postdoctoral training in Pediatric Clinical PharmacologyT32HD087969 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI VAN DEN ANKER, JOHANNES NICOLAAS · 2016 to 2020
$998k
Prevention of postpartum hemorrhage: identifying pregnant women at risk and determining the safe and effective use of tranexamic acid using state-of-the-art pharmacokinetic/pharmacodynamics modelingK23HL141640 · NHLBI · GEORGE WASHINGTON UNIVERSITY · PI AHMADZIA, HOMA KHORRAMI · 2019 to 2022
$621k
NCATS NIH HHS KL2 TR001877NCATS NIH HHS UL1 TR001876NHLBI NIH HHS K23 HL141640NHLBI NIH HHS R01 HL126974NHLBI NIH HHS R33 HL141791NHLBI NIH HHS R61 HL141791NHLBI NIH HHS U01 HL143403NICHD NIH HHS T32 HD087969
6 · The paper itself

Abstract

aimsThe population pharmacokinetics (PK) and pharmacodynamics (PD) of tranexamic acid (TXA) have not been studied to prevent postpartum haemorrhage (PPH) in pregnant women. It is unclear which TXA dose assures sufficient PPH prevention. This study investigated population PK/PD of TXA in pregnant women who underwent caesarean delivery to determine the optimal prophylactic doses of TXA for future studies.

methodsWe analysed concentration (PK) and maximum lysis (PD) data from 30 pregnant women scheduled for caesarean delivery who received 5, 10 or 15 mg/kg of TXA intravenously using population approach.

resultsTXA PK was best described by a two-compartment model with first-order elimination and the following parameters: clearance (between-subject variability) of 9.4 L/h (27.7%), central volume of 10.1 L (47.4%), intercompartmental clearance of 22.4 L/h (66.7%), peripheral volume of 14.0 L (13.1%) and additive error of 1.4 mg/L. The relationship between TXA concentration and maximum lysis was characterized by a sigmoid Emax model with baseline lysis of 97%, maximum inhibition of 89%, IC

conclusionThis is the first population PK and PD study of TXA in pregnant women undergoing caesarean delivery. Our analysis suggests that a 650 mg dose provides adequate PPH prophylaxis up to 1 hour, which is less than the currently used 1000 mg of TXA in pregnant women.

Indexed as

Antifibrinolytic AgentsPostpartum HemorrhageTranexamic AcidCesarean SectionFemaleHumansPregnancyAntifibrinolytic AgentsTranexamic Acidpopulation pharmacodynamicspopulation pharmacokineticspost-partum haemorrhageprophylaxisTXA

Identifiers

PMID33576009
PMCPMC8355246
OpenAlexW3128981038

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Registered trials

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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.