Prevention of Postpartum Hemorrhage With Tranexamic Acid

Overview

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.

Full Title of Study: “Prevention of Postpartum Hemorrhage: Identifying Pregnant Women at Risk and Determining the Safe and Effective Use of Tranexamic Acid Using State-of-the-art Pharmacokinetic/Pharmacodynamics Modeling”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2023

Detailed Description

Conduct a prospective, open-label, dose finding PK study in 30 pregnant 3rd trimester women scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of the drug will be administered in an escalating fashion by cohort with the lowest dose first. A maximum of 1 gram will be administered. TXA serum levels at several time points after delivery will be assayed. A PK model will be constructed for determining the optimal TXA dose administered at parturition.

Interventions

  • Drug: Tranexamic Acid
    • 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.

Arms, Groups and Cohorts

  • Experimental: Cohort 1
    • Dose of Tranexamic acid 5mg/kg will be administered.
  • Experimental: Cohort 2
    • Dose of Tranexamic acid 10 mg/kg will be administered.
  • Experimental: Cohort 3
    • Dose of Tranexamic acid 15 mg/kg will be administered.

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics of Tranexamic Acid
    • Time Frame: Different time points ranging from surgery (T0) to 1 day postpartum.
    • Serum Assay of TXA in blood and breast milk to determine clearance.
  • Pharmacodynamics of Tranexamic acid
    • Time Frame: Different time points ranging from surgery (T0) to 1 day postpartum.
    • Pharmacodynamics: maximum lysis (ML) and other coagulation markers such as d-dimer and plasmin-anti-plasmin complexes

Secondary Measures

  • Estimated blood loss
    • Time Frame: During surgery
    • Intraoperative blood loss
  • Safety parameters
    • Time Frame: During surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartum
    • Safety parameters such as adverse events and serious adverse events

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • 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

Gender Eligibility: Female

Pregnant women in 3rd trimester of pregnancy

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • George Washington University
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Homa Ahmadzia, PI – George Washington University
  • Overall Official(s)
    • Homa Ahmadzia, MD, Principal Investigator, George Washington University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.