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

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ClinicalTrials.gov Identifier: NCT02806024
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : March 7, 2019
Sponsor:
Collaborators:
Central California Faculty Medical Group
University of California, San Francisco Fresno
Information provided by (Responsible Party):
Mallory Kremer, 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.

Condition or disease Intervention/treatment Phase
Placenta Accreta Postpartum Hemorrhage Cesarean Section Tranexamic Acid Drug: Tranexamic Acid Drug: Placebo Drug Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial
Actual Study Start Date : November 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02806024


Locations
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United States, California
Community Regional Medical Center
Fresno, California, United States, 93721
Sponsors and Collaborators
University of California, San Francisco
Central California Faculty Medical Group
University of California, San Francisco Fresno

Publications:
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Responsible Party: Mallory Kremer, Principle Investigator, Clinical Instructor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02806024     History of Changes
Other Study ID Numbers: 2016036
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Placenta Previa
Placenta Accreta
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Placenta Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants