Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 3/9/2019 |
| Start Date: | November 2016 |
| End Date: | August 2018 |
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial
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.
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.
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.
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)
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