Skip to main content

Summary

Eligibility
for females ages 18–60
Location
at Fresno, California
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Official Title

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

Details

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.

Keywords

Placenta Accreta Postpartum Hemorrhage Cesarean Section Tranexamic Acid

Eligibility

You can join if…

Open to females ages 18–60

  • 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

You CAN'T join if...

  • 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)

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02806024
Phase
Phase 4
Lead Scientist
Mallory Kremer
Study Type
Interventional
Last Updated
June 2016
I’m interested in this study!