Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study

Phase 4

Completed

• Conditions: Placenta Accreta; Postpartum Hemorrhage; Cesarean Section; Tranexamic Acid
• Interventions: Drug: Tranexamic Acid; Drug: Placebo Drug

• Registration Number: NCT02806024
• Lead Sponsor: University of California, San Francisco

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 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.

Study Timeline

• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Study Start: 2016-11
• Primary Completion: 2018-07
• Study Completion: 2018-08
• Results First Submitted: 2019-09-16
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-14
• Last Update Submitted: 2019-11-14
• Results First Posted: 2019-12-03
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm (Tranexamic Acid, or TXA)	Tranexamic Acid	Patients will be randomized to treatment or placebo arms preoperatively. In our treatment arm of pregnant patients with suspected placenta accreta or at high risk for placenta accreta, patients will receive 1 gram intravenous TXA administered over 10 minutes immediately after delivery of the infant. The drug will be prepared and ready to hang at the beginning of the case. The study drug will be administered only once.
Placebo Arm	Placebo Drug	Patients will be randomized to treatment or placebo arms preoperatively. In our placebo arm of pregnant patients with suspected placenta accreta, patients will receive plain normal saline in a 50 cc bag identical to the preparation of study drug immediately after delivery of the infant.

Primary Outcome Measures

Name	Time	Method
Estimated Blood Loss (EBL)	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 Outcome Measures

Name	Time	Method
Blood Transfusion (Number of Units Transfused) Intraoperatively	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.

Trial Locations

Locations (1)

Community Regional Medical Center; 🇺🇸 Fresno, California, United States