Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage

Completed · Early Phase 1

Conditions studied: Postpartum Hemorrhage

In brief

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 (ROTEM®) 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.

Key facts

Study ID

NCT03863964

Run by

Brigham and Women's Hospital

People needed

20

Starts

2019-06-01

Expected to finish

2021-03-01

Last updated by the study team

2021-04-13

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• Allergy to tranexamic acid, inherited thrombophilia, history/current/intrapartum venous thrombosis, seizure disorder, renal or liver dysfunction, preeclampsia, anticoagulation therapy, or category III fetal heart rate tracing.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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