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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 is a Early Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03863964
The ClinicalTrials.gov registry entry for NCT03863964 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which blood test is the first listed.
NCT03863964 reports 0 study locations.
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.
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