Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 1, 2019

Primary Completion Date

January 31, 2021

Study Completion Date

March 1, 2021

Conditions
Postpartum Hemorrhage
Interventions
DIAGNOSTIC_TEST

blood test

13 blood samples will be drawn: at 3 min, 7 min, 15 min, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, and 5h 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.

Trial Locations (1)

02115

Brigham and Women's Hospital, Boston

All Listed Sponsors
lead

Brigham and Women's Hospital

OTHER

NCT03863964 - Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage | Biotech Hunter | Biotech Hunter