Prevention of Postpartum Hemorrhage With Tranexamic Acid

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cohort 1

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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.

Cohort 2

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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.

Cohort 3

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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TXA; Cyklokapron

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes