Last reviewed · How we verify
NCT03863964
Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage
EARLY_PHASE1 trial testing blood test in Postpartum Hemorrhage in 20 participants. Completed in 1 March 2021.
31 January 2021
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 June 2019 |
| Primary completion | 31 January 2021 |
| Estimated completion | 1 March 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- blood test — full drug profile →
Conditions studied
- Postpartum Hemorrhage — all drugs for Postpartum Hemorrhage →
Sponsor
Brigham and Women's Hospital
Who can join
Adults 18 to 50, female only, with Postpartum Hemorrhage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Transfusion strategies in bleeding critically ill adults: a clinical practice guideline from the European Society of Intensive Care Medicine.
Vlaar APJ, Dionne JC, de Bruin S, Wijnberge M, et al · · 2021 · cited 65× · PMID 34677620 · DOI 10.1007/s00134-021-06531-x -
Evaluating Tranexamic Acid Dosing Strategies for Postpartum Hemorrhage: A Population Pharmacokinetic Approach in Pregnant Individuals.
Dunn A, Felfeli M, Seifert SM, Gilliot S, et al · · 2025 · PMID 40384366 · DOI 10.1002/jcph.70031
Verify or expand the search:
- PubMed search for NCT03863964
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of blood test
Trials testing the same drug.
- NCT06971289 — Development and Characterization of Functional Assays for the Analysis of Inflammation Signaling Pathways · not yet recruiting
- NCT06983197 — Iatrogenic Deficiencies in ICU Patients With Prolonged Continuous Renal Replacement Therapy · not yet recruiting
- NCT06375889 — Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage · completed
- NCT05901207 — Diagnostic and Prognostic Biomarkers for IgG4-related Disease. · unknown
- NCT06212505 — EVALUATION of the OVERALL HAEMOSTATIC CAPACITY of MIM8 with GLOBAL HAEMOSTASIS ASSAYS and FIBRIN CLOT ULTRASTRUCTURE · completed
Other recruiting trials for Postpartum Hemorrhage
Currently open trials in the same condition.
- NCT07401160 — Umbilical Cord Drainage to Prevent Postpartum Hemorrhage · NA · recruiting
- NCT07278037 — Trends in the Administration of Tranexamic Acid for Postpartum Hemorrhage · recruiting
- NCT07279545 — The Effect of Placental Cord Drainage on the Third Stage of Labor and the Amount of Postpartum Bleeding · NA · recruiting
- NCT07229573 — The Effectiveness of Serious Game-Based Training for Nursing Students in Postpartum Haemorrhage Management · NA · recruiting
- NCT07005349 — THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage · NA · recruiting
Other Brigham and Women's Hospital trials
Trials by the same sponsor.
- NCT07011758 — Dynamic Treatment Regimes for Opioid Use Disorder · Phase 2 · not yet recruiting
- NCT06310018 — Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE · suspended
- NCT04519177 — Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ... · NA · not yet recruiting
- NCT06355986 — Computerized Decision Support to Prevent Stroke in Atrial Fibrillation · NA · not yet recruiting
- NCT06099275 — Evaluation of Hemodynamics in People With Untreated Preeclampsia Using Echocardiography · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03863964 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Brigham and Women's Hospital
- Last refreshed: 13 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03863964.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing