Skip to main content
OpenTrials
Completed

NCT Number: NCT02806024

Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tranexamic Acid

Drug

Placebo drug

Drug

50 cc Normal Saline IV

Primary outcomes

  1. Estimated Blood Loss (EBL)

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

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

Secondary outcomes

  1. Blood Transfusion (Number of Units Transfused) Intraoperatively

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

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Central California Faculty Medical Group

Registry information

Official study title

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

Acronym: TAPPAS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2016
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.