Prevention of Postpartum Hemorrhage With Tranexamic Acid

NCT03287336 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: IND134701UL1TR001876KL2TR001877K23HL141640
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum hemorrhage is a significant contributor to maternal morbidity and mortality and is worldwide. TXA has recently been proven to reduce mortality when given to women in setting of diagnosed PPH. US obstetricians and anesthesiologists are hesitant to use TXA in the peripartum period especially for prevention of PPH due to uncertainty of an optimal dose and safety profile. The purpose of this study is to characterize the pharmacokinetics of TXA when given prophylactically at time of delivery. In addition investigators will determine the pharmacodynamics of TXA in the peripartum period.

Conditions

Postpartum Hemorrhage

Keywords

tranexamic acid; postpartum hemorrhage

Outcome Measures

Primary Outcomes (2)

• PK Model Parameter Estimates

  Data obtained from assays of TXA in blood, dose group and patient characteristics; parameter estimates in 2 compartment model includes the clearance of the drug (L/hr).

  Different time points ranging from surgery (T0) to 1 day postpartum.

• Pharmacodynamics of Tranexamic Acid

  PD model parameters included concentration of TXA causing 50% of maximal fractional inhibition (IC50).

  Different time points ranging from surgery (T0) to 1 day postpartum.

Secondary Outcomes (2)

• Estimated Blood Loss

  During surgery

• Safety Parameters

  During surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartum

Study Arms (3)

Cohort 1

EXPERIMENTAL

Dose of Tranexamic acid 5mg/kg will be administered.

Drug: Tranexamic Acid

Cohort 2

EXPERIMENTAL

Dose of Tranexamic acid 10 mg/kg will be administered.

Drug: Tranexamic Acid

Cohort 3

EXPERIMENTAL

Dose of Tranexamic acid 15 mg/kg will be administered.

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.

Also known as: TXA; Cyklokapron

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant women in 3rd trimester of pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who are undergoing medically indicated cesarean section at greater than 34+0 weeks gestation or women undergoing elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists
• Pregnant women with normal serum creatinine (serum creatinine \< 0.9)
• Women between the ages of 18 and 50 years old

You may not qualify if:

• Patients younger than 18 or older than 50
• women with active thrombotic or thromboembolic disease
• Women with a history of arterial or venous thromboembolic event
• Women with inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome)
• Women with a subarachnoid hemorrhage
• Women with acquired defective color vision
• history of seizure disorder
• known renal dysfunction
• multiple gestations (Twin or triplet pregnancies)
• Hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy
• History of liver dysfunction

Sponsors & Collaborators

• George Washington University: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

James Slota

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

• Ahmadzia HK, Luban NLC, Li S, Guo D, Miszta A, Gobburu JVS, Berger JS, James AH, Wolberg AS, van den Anker J. Optimal use of intravenous tranexamic acid for hemorrhage prevention in pregnant women. Am J Obstet Gynecol. 2021 Jul;225(1):85.e1-85.e11. doi: 10.1016/j.ajog.2020.11.035. Epub 2020 Nov 26.

  PMID: 33248975 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Homa K. Ahmadzia
• Organization: GW University

homa.khorrami@gmail.com

2027412500

Study Officials

• Homa Ahmadzia, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Three doses of Tranexamic acid (5 mg/kg, 10 mg/kg, and 15 mg/kg) will be used in a dose escalation fashion by cohort with the lowest dose first.

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: September 19, 2017
• Study Start: January 2, 2018
• Primary Completion: September 1, 2023
• Study Completion: September 30, 2023
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)