Evidence map›Paper›PMID 33248975›Full record

ArticleAmerican journal of obstetrics and gynecology2021

Optimal use of intravenous tranexamic acid for hemorrhage prevention in pregnant women.

Homa K Ahmadzia, Naomi L C Luban, Shuhui Li, Dong Guo, Adam Miszta, Jogarao V S Gobburu, Jeffrey S Berger, Andra H James, Alisa S Wolberg, John van den Anker

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PubMed Full text at PMC Publisher
In one paragraph

Article in American journal of obstetrics and gynecology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
8.2field-weighted citation impact, top 2% 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

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  6. Article
  7. Article
  8. Review
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  10. Management of pregnant women who have bleeding disorders.Hematology. American Society of Hematology. Education Program · 2023
    Article
  11. Article
  12. Alternative routes to intravenous tranexamic acid for postpartum hemorrhage: A systematic search and narrative review.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2022
    Review
  13. Disorders of Fibrinogen and Fibrinolysis.Hematology/oncology clinics of North America · 2021
    Review
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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

10 authors at 5 institutions in 3 countries.

Homa K AhmadziaDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, George Washington University, Washington, DC. Electronic address: hahmadzia@mfa.gwu.edu.
Naomi L C LubanDivision of Pathology and Laboratory Medicine, Children's National Hospital, Washington, DC.
Shuhui LiDepartment of Pharmacy Practice and Science, School of Pharmacy, University of Maryland, Baltimore, Baltimore, MD.
Dong GuoDepartment of Pharmacy Practice and Science, School of Pharmacy, University of Maryland, Baltimore, Baltimore, MD.
Adam MisztaDepartment of Pathology and Laboratory Medicine and University of North Carolina Blood Research Center, The University of North Carolina at Chapel Hill, Chapel Hill, NC; Synapse Research Institute, Maastricht, the Netherlands.
Jogarao V S GobburuDepartment of Pharmacy Practice and Science, School of Pharmacy, University of Maryland, Baltimore, Baltimore, MD.
Jeffrey S BergerDepartment of Anesthesiology and Critical Care Medicine, George Washington University, Washington, DC.
Andra H JamesDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Duke University, Durham, NC.
Alisa S WolbergDepartment of Pathology and Laboratory Medicine and University of North Carolina Blood Research Center, The University of North Carolina at Chapel Hill, Chapel Hill, NC.
John van den AnkerDivision of Clinical Pharmacology, Children's National Hospital, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, Basel, Switzerland.
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

backgroundEvery 2 minutes, there is a pregnancy-related death worldwide, with one-third caused by severe postpartum hemorrhage. Although international trials demonstrated the efficacy of 1000 mg tranexamic acid in treating postpartum hemorrhage, to the best of our knowledge, there are no dose-finding studies of tranexamic acid on pregnant women for postpartum hemorrhage prevention.

objectiveThis study aimed to determine the optimal tranexamic acid dose needed to prevent postpartum hemorrhage. STUDY

designWe enrolled 30 pregnant women undergoing scheduled cesarean delivery in an open-label, dose ranging study. Subjects were divided into 3 cohorts receiving 5, 10, or 15 mg/kg (maximum, 1000 mg) of intravenous tranexamic acid at umbilical cord clamping. The inclusion criteria were ≥34 week's gestation and normal renal function. The primary endpoints were pharmacokinetic and pharmacodynamic profiles. Tranexamic acid plasma concentration of >10 μg/mL and maximum lysis of <17% were defined as therapeutic targets independent to the current study. Rotational thromboelastometry of tissue plasminogen activator-spiked samples was used to evaluate pharmacodynamic profiles at time points up to 24 hours after tranexamic acid administration. Safety was assessed by plasma thrombin generation, D-dimer, and tranexamic acid concentrations in breast milk.

resultsThere were no serious adverse events including venous thromboembolism. Plasma concentrations of tranexamic acid increased in a dose-proportional manner. The lowest dose cohort received an average of 448±87 mg tranexamic acid. Plasma tranexamic acid exceeded 10 μg/mL and maximum lysis was <17% at >1 hour after administration for all tranexamic acid doses tested. Median estimated blood loss for cohorts receiving 5, 10, or 15 mg/kg tranexamic acid was 750, 750, and 700 mL, respectively. Plasma thrombin generation did not increase with higher tranexamic acid concentrations. D-dimer changes from baseline were not different among the cohorts. Breast milk tranexamic acid concentrations were 1% or less than maternal plasma concentrations.

conclusionAlthough large randomized trials are necessary to support the clinical efficacy of tranexamic acid for prophylaxis, we propose an optimal dose of 600 mg in future tranexamic acid efficacy studies to prevent postpartum hemorrhage.

Indexed as

AdultCesarean SectionDose-Response Relationship, DrugFemaleFibrin Fibrinogen Degradation ProductsGestational AgeHumansMilk, HumanPostpartum HemorrhagePregnancyThrombelastographyTranexamic AcidTreatment OutcomeYoung AdultFibrin Fibrinogen Degradation Productsfibrin fragment DTranexamic Acidpharmacodynamicpharmacokineticpostpartum hemorrhagepreventiontranexamic acid

Identifiers

PMID33248975
PMCPMC8149481
OpenAlexW3110280868

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.