Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study — TAPPAS  

Cesarean Section Clinical Trial

Official title: Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Cesarean Section
• Hemorrhage
• Placenta Accreta
• Placenta Previa
• Postpartum Hemorrhage
• Tranexamic Acid

• NCT number: NCT02806024
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Completion date: August 2018