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Prevention of Postpartum Hemorrhage With Tranexamic Acid

Primary Purpose

Postpartum Hemorrhage

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring tranexamic acid, postpartum hemorrhage

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • James Slota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetics of Tranexamic Acid
Serum Assay of TXA in blood and breast milk to determine clearance.
Pharmacodynamics of Tranexamic acid
Pharmacodynamics: maximum lysis (ML) and other coagulation markers such as d-dimer and plasmin-anti-plasmin complexes

Secondary Outcome Measures

Estimated blood loss
Intraoperative blood loss
Safety parameters
Safety parameters such as adverse events and serious adverse events

Full Information

First Posted
June 27, 2017
Last Updated
October 17, 2022
Sponsor
George Washington University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03287336
Brief Title
Prevention of Postpartum Hemorrhage With Tranexamic Acid
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
tranexamic acid, postpartum hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
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
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Dose of Tranexamic acid 5mg/kg will be administered.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Dose of Tranexamic acid 10 mg/kg will be administered.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Dose of Tranexamic acid 15 mg/kg will be administered.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
TXA; Cyklokapron
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharmacokinetics of Tranexamic Acid
Description
Serum Assay of TXA in blood and breast milk to determine clearance.
Time Frame
Different time points ranging from surgery (T0) to 1 day postpartum.
Title
Pharmacodynamics of Tranexamic acid
Description
Pharmacodynamics: maximum lysis (ML) and other coagulation markers such as d-dimer and plasmin-anti-plasmin complexes
Time Frame
Different time points ranging from surgery (T0) to 1 day postpartum.
Secondary Outcome Measure Information:
Title
Estimated blood loss
Description
Intraoperative blood loss
Time Frame
During surgery
Title
Safety parameters
Description
Safety parameters such as adverse events and serious adverse events
Time Frame
During surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women in 3rd trimester of pregnancy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Homa Ahmadzia, MD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
James Slota
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33248975
Citation
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.
Results Reference
derived

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Prevention of Postpartum Hemorrhage With Tranexamic Acid

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