Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study

University of California, San Francisco14 enrolled

Overview

The purpose of this pilot study is to determine if intravenous tranexamic acid (TXA) is effective for reducing blood loss during high risk surgical procedures related to placenta previa and placenta accreta. TXA is currently used in other types of surgery for patients who are expected to have a large blood loss, such as orthopedic or open heart surgery.

To date, no novel or pharmacologic methods of reducing blood loss have been described for women at risk for placenta accreta. Intravenous tranexamic acid (TXA), a drug with anti-fibrinolytic activity, is routinely used in elective orthopedic and cardiac surgery to reduce blood loss. Intravenous tranexamic acid is currently FDA approved for use in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty to reduce peri- and post-operative blood loss and to reduce the need for blood transfusion. There has been growing interest in the application of tranexamic acid in obstetrics and gynecology. In multiple international studies, intravenous TXA has been shown to significantly reduce blood loss when given prophylactically with cesarean delivery or vaginal delivery without an increase in morbidity from adverse thrombotic events. TXA has not been studied in the particular population of patients requiring cesarean hysterectomy for placenta previa or accreta. This inexpensive, low risk medication has potential to greatly reduce perioperative morbidity and cost when used in a high risk obstetrical population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Placenta Accreta Postpartum Hemorrhage Cesarean Section Tranexamic Acid

Interventions

Tranexamic AcidDRUG

Placebo DrugDRUG

50 cc Normal Saline IV

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * English and Spanish speaking pregnant women * Any order pregnancy (singleton, twin gestation, etc) * Suspected accreta based on ultrasound or MRI imaging studies * All women evaluated for placenta accreta and deemed to be high risk for this disease (≥40% risk), meaning women diagnosed with a placenta previa and greater than or equal to 2 prior c-sections Exclusion Criteria: * Women less than 18 years of age * Women with a personal history of venous or arterial thrombosis (deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke * Women with a personal history of a high risk clotting disorder, such as anti-phospholipid syndrome * Women who do not have a good understanding of either English or Spanish will be excluded. * Women with defective color vision (color-blindness)

Locations (1)

Community Regional Medical Center

Fresno, California, United States

Outcomes

Primary Outcomes

Estimated Blood Loss (EBL)

EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery \&/or cesarean hysterectomy).

Time frame: 1-3 hours (will be determined at the completion of the surgery).

Secondary Outcomes

Blood Transfusion (Number of Units Transfused) Intraoperatively

Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) intra-operatively is a secondary outcome.

Time frame: Pulled from operative note, completed by the time of discharge.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.