Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage
Tranexamic Acid Administered After Delivery: Maternal Pharmacokinetics, Pharmacodynamics, and Coagulation Status
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2018
CompletedFirst Posted
Study publicly available on registry
March 5, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedApril 13, 2021
April 1, 2021
1.7 years
December 11, 2018
April 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
TXA plasma concentration at baseline
measured by ultra-performance liquid chromatography and mass spectometry
baseline (before delivery, before treatment with TXA)
TXA plasma concentration 15 minutes after treatment
measured by ultra-performance liquid chromatography and mass spectometry
after TXA administration: 15 minutes
TXA plasma concentration 30 minutes after treatment
measured by ultra-performance liquid chromatography and mass spectometry
after TXA administration: 30 minutes
TXA plasma concentration 1 hour after treatment
measured by ultra-performance liquid chromatography and mass spectometry
after TXA administration: 1 hour
TXA plasma concentration 1.5 hours after treatment
measured by ultra-performance liquid chromatography and mass spectometry
after TXA administration: 1.5 hours
TXA plasma concentration 2 hours after treatment
measured by ultra-performance liquid chromatography and mass spectometry
after TXA administration: 2 hours
TXA plasma concentration 2.5 hours after treatment
measured by ultra-performance liquid chromatography and mass spectometry
after TXA administration: 2.5 hours
Secondary Outcomes (8)
Rotational Thromboelastometry (ROTEM®) coagulation test at baseline
baseline (before delivery, before treatment with TXA)
Rotational Thromboelastometry (ROTEM®) coagulation test at 15 minutes
after TXA administration: 15 minutes
Rotational Thromboelastometry (ROTEM®) coagulation test at 30 minutes
after TXA administration: 30 minutes
Rotational Thromboelastometry (ROTEM®) coagulation test at 1 hour
after TXA administration: 1 hour
Rotational Thromboelastometry (ROTEM®) coagulation test at 1.5 hours
after TXA administration: 1.5 hours
- +3 more secondary outcomes
Study Arms (13)
plasma TXA and ROTEM test at 3 minutes
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 7 minutes
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 15 minutes
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 30 minutes
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 1 hour
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 1.5 hours
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 2 hours
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 2.5 hours
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 3 hours
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 3.5 hours
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 4 hours
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 4.5 hours
ACTIVE COMPARATORBlood test
plasma TXA and ROTEM test at 5 hours
ACTIVE COMPARATORBlood test
Interventions
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.
Eligibility Criteria
You may qualify if:
- Major (1) or more:
- Suspected abnormal placentation
- Placenta previa
- Known coagulopathy
- Active concern for bleeding per care team
- Minor (2) or more:
- prior cesarean deliveries
- prior deliveries
- Prior history of PPH
- Chorioamnionitis
- Polyhydramnios
- Macrosomia
- Obesity
- Suspected placental abruption
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michaela K Farber, MD MS
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 11, 2018
First Posted
March 5, 2019
Study Start
June 1, 2019
Primary Completion
January 31, 2021
Study Completion
March 1, 2021
Last Updated
April 13, 2021
Record last verified: 2021-04