Prevention of Postpartum Hemorrhage With Tranexamic Acid

George Washington University (GW)

Status and phase: Completed; Phase 2

Conditions: Postpartum Hemorrhage

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03287336

UL1TR001876 (U.S. NIH Grant/Contract)

IND134701

KL2TR001877 (U.S. NIH Grant/Contract)

K23HL141640 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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43 participants in 3 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid