Prevention of Postpartum Hemorrhage With Tranexamic Acid

George Washington University43 enrolled

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.

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

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic AcidDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

James Slota

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

Outcomes

Primary Outcomes

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).

Time frame: 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).

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

Secondary Outcomes

Estimated Blood Loss

Intraoperative blood loss

Time frame: During surgery

Safety Parameters

Safety parameters such as adverse events (including nausea/vomiting) and serious adverse events

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

Data from ClinicalTrials.gov

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