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NCT03863964 · ClinicalTrials.gov registry record · Early Phase 1
Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage
A Early Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT03863964: Completed Early Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT03863964 is a Early Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03863964, a Early Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
measured by ultra-performance liquid chromatography and mass spectometry
Interventions
- DIAGNOSTIC_TEST blood test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2021-03-01 |
| Phase | Early Phase 1 |
What the finished NCT03863964 record still lists
NCT03863964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which blood test is the first listed.
NCT03863964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03863964 about?
NCT03863964 is a clinical study titled "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 stud...
What is the current status of trial NCT03863964?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2019-06-01. Estimated completion is 2021-03-01.
What interventions are being tested in trial NCT03863964?
The interventions under investigation include: blood test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03863964?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03863964's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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