TRAnexamic acid in hemorrhagic CESarean section (TRACES) randomized placebo controlled dose-ranging pharmacobiological ancillary trial: study protocol for a randomized controlled trial

Trials
Anne-Sophie Ducloy-BouthorsBenjamin Hennart

Abstract

Evidence increases that a high or a standard dose of tranexamic acid (TA) reduces postpartum bleeding. The TRACES pharmacobiological substudy aims to establish a therapeutic strategy in hemorrhagic (H) Cesarean section (CS) with respect to the intensity of fibrinolysis by using innovative assays. The TRACES trial is a multicenter, randomized, double-blind, placebo-controlled, TA dose-ranging study that measures simultaneously plasmatic and uterine and urine TA concentrations and the plasmin peak inhibition tested by a simultaneous thrombin plasmin generation assay described by Van Geffen (novel hemostasis assay [NHA]). Patients undergoing H CS (>800 mL) will receive blindly TA 0.5 g or 1 g or placebo. A non-hemorrhagic (NH) group will be recruited to establish plasmin generation profile. Venous blood will be sampled before, at the end, and then at 30, 60, 120, and 360 min after injection. Uterine bleeding will be sampled after injection. Urine will be sampled 2 h and 6 h after injection. The number of patients entered into the study will be 114 H + 48 NH out of the 390 patients of the TRACES clinical trial. To explore the two innovative assays, a preliminary pilot study was conducted. Blood samples were performed repeatedly in ...Continue Reading

Associated Clinical Trials

Feb 27, 2019·Olutoyosi Ogunkua, MD, Olutoyosi Ogunkua, MD

References

Jan 1, 1987·Scandinavian Journal of Gastroenterology. Supplement·B Astedt
Jan 1, 1980·Acta Obstetricia Et Gynecologica Scandinavica·L SvanbergI M Nilsson
Jan 1, 1982·Archives of Toxicology. Supplement. = Archiv Für Toxikologie. Supplement·M Walzman, J Bonnar
Jan 1, 1981·European Journal of Clinical Pharmacology·A PilbrantJ Vessman
Feb 1, 1995·Anesthesiology·J C HorrowJ L Parmet
Aug 2, 2002·Anesthesiology·Noreen P DowdJohn Butterworth
Jun 2, 2004·Pathophysiology of Haemostasis and Thrombosis·C Biron-AndréaniH Dechaud
Nov 8, 2006·Journal of Thrombosis and Haemostasis : JTH·B CharbitUNKNOWN PPH Study Group
Dec 31, 2009·Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis·Thorsten AnneckeBernhard Heindl
Jan 29, 2011·Journal of Cardiothoracic and Vascular Anesthesia·Klaus MartinGunther Wiesner
Apr 19, 2011·Critical Care : the Official Journal of the Critical Care Forum·Anne-Sophie Ducloy-BouthorsSophie Susen
Nov 9, 2011·Canadian Journal of Anaesthesia = Journal Canadien D'anesthésie·Rizwan A ManjiEric Jacobsohn
May 23, 2012·BMJ : British Medical Journal·Katharine KerIan Roberts
Jan 15, 2014·Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis·Roland CouturierStanislas Grassin-Delyle

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Citations

Aug 21, 2018·Current Opinion in Hematology·Elizabeth A Godbey, Joseph Schwartz
Sep 2, 2020·The Cochrane Database of Systematic Reviews·Sandra A ZimpelEdina Mk da Silva
Mar 5, 2020·Scientific Reports·Ivan D TarandovskiyPaul W Buehler
Mar 12, 2020·Archives of Gynecology and Obstetrics·Lars SchröderWaltraut Maria Merz
Jul 28, 2020·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·S GilliotP Odou
Nov 30, 2020·American Journal of Obstetrics and Gynecology·Homa K AhmadziaJohn van den Anker

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Methods Mentioned

BETA
hysterectomy
Cesarean section
Cesarean

Software Mentioned

TRACES
Excel
EXADELI
Excel®
MassLynx
Ascent
SAS
GraphPad Prism®

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