Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS)

November 14, 2019 updated by: Mallory Kremer, University of California, San Francisco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93721
        • Community Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm (Tranexamic Acid, or TXA)
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.
Drug: Tranexamic Acid
Placebo Comparator: Placebo Arm
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.
Drug: Placebo Drug
50 cc Normal Saline IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1-3 hours (will be determined at the completion of the surgery).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pulled from operative note, completed by the time of discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Central California Faculty Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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