Clinical Trial: Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: University of California, San Francisco

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Blood transfusion (number of units transfused) [ Time Frame: One week. The number of units given, if any, will be tallied at the time of hospital discharge, which should be less than a one week period (average length of stay is 4-5 days). ]
    Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) during the entire hospital admission is a secondary outcome.
  • ICU admission [ Time Frame: One week. Total number of days spent in the ICU, if any, will be tallied at the time of hospital discharge, which should be less than a one week period (average length of stay is 4-5 days). ]
    A secondary outcome will be length of ICU admission post operatively


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: June 10, 2016
Date Started: October 2016
Date Completion: July 2019
Last Updated: October 12, 2016
Last Verified: June 2016