ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Postpartum Hemorrhage With Tranexamic Acid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03287336
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Homa Ahmadzia, George Washington University

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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Tranexamic Acid Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
Dose of Tranexamic acid 5mg/kg will be administered.
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.
Other Name: TXA; Cyklokapron

Experimental: Cohort 2
Dose of Tranexamic acid 10 mg/kg will be administered.
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.
Other Name: TXA; Cyklokapron

Experimental: Cohort 3
Dose of Tranexamic acid 15 mg/kg will be administered.
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.
Other Name: TXA; Cyklokapron




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Estimated blood loss [ Time Frame: During surgery ]
    Intraoperative blood loss

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women in 3rd trimester of pregnancy
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287336


Contacts
Contact: Alexandra North, BS (202)741-2592 anorth@mfa.gwu.edu
Contact: Homa Ahmadzia, MD (202)741-2593 hahmadzia@mfa.gwu.edu

Locations
United States, District of Columbia
George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Ebonie Carter, BS    202-741-2592    ecarter@mfa.gwu.edu   
Sponsors and Collaborators
Homa Ahmadzia
National Institutes of Health (NIH)
Investigators
Principal Investigator: Homa Ahmadzia, MD George Washington University

Responsible Party: Homa Ahmadzia, Principal Investigator, George Washington University
ClinicalTrials.gov Identifier: NCT03287336     History of Changes
Other Study ID Numbers: IND134701
UL1TR001876 ( U.S. NIH Grant/Contract )
KL2TR001877 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Homa Ahmadzia, George Washington University:
tranexamic acid
postpartum hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants