Clinical Trial

Tranexamic Acid Pharmacokinetics in Postpartum Hemorrhage

Study Description

Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage

Postpartum hemorrhage (PPH) accounts for 20-25 percent of maternal deaths worldwide. Tranexamic Acid (TXA) is an antifibrinolytic agent that has been shown to reduce the estimated blood loss after delivery and is recommended by the World Health Organization for PPH treatment. However, dosing in studies ranges from 0.5g to 4g and the optimal dose of TXA in the pregnant population has not been established. Further, the effect of TXA on global coagulation assessed by rotational thromboelastometry (ROTEMAR) has not been elucidated. The primary aim of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of TXA administered after delivery in patients at risk for PPH.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Diagnostic Test - blood test

8 blood samples will be drawn: 1 at time of admission, then 15 min, 30min, 1h, 1.5h, 2h, 2.5h, and 3h post-treatment with TXA. Blood samples will be processed for ROTEM® analysis and for plasma concentration of TXA. TXA plasma concentrations will be modeled with a non-linear mixed-effects strategy using Monolix 4.1 and NONMEM(®) 7.2.

Additional Information

Official Study Title

Tranexamic Acid Administered After Delivery: Maternal Pharmacokinetics, Pharmacodynamics, and Coagulation Status

Clinical Trial ID

NCT03863964

ParticipAid ID

ejRBYe