Prevention of Postpartum Hemorrhage With Tranexamic Acid

Postpartum Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03287336
• Other study ID #: IND134701
• Secondary ID: UL1TR001876KL2TR
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 2, 2018
• Est. completion date: November 1, 2023

Study information

• Verified date: October 2022
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: November 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	James Slota	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
George Washington University	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Tranexamic Acid	Serum Assay of TXA in blood and breast milk to determine clearance.	Different time points ranging from surgery (T0) to 1 day postpartum.
Primary	Pharmacodynamics of Tranexamic acid	Pharmacodynamics: maximum lysis (ML) and other coagulation markers such as d-dimer and plasmin-anti-plasmin complexes	Different time points ranging from surgery (T0) to 1 day postpartum.
Secondary	Estimated blood loss	Intraoperative blood loss	During surgery
Secondary	Safety parameters	Safety parameters such as adverse events and serious adverse events	During surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartum