Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS)
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial
Sponsor: Central California Faculty Medical Group
A PHASE4 clinical study on Cesarean Section and Placenta Accreta, this trial is completed. The trial is conducted by Central California Faculty Medical Group and has accumulated 10 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)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.
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.
Status Flow
Change History
10 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE4
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Sep 2024 — Present [monthly]
Completed PHASE4
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
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Feb 2023 — Jul 2024 [monthly]
Completed PHASE4
-
Jan 2021 — Feb 2023 [monthly]
Completed PHASE4
▶ Show 5 earlier versions
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Jan 2020 — Jan 2021 [monthly]
Completed PHASE4
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Apr 2019 — Jan 2020 [monthly]
Completed PHASE4
Status: Recruiting → Completed
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Jun 2018 — Apr 2019 [monthly]
Recruiting PHASE4
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Feb 2017 — Jun 2018 [monthly]
Recruiting PHASE4
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Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE4
First recorded
Nov 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Central California Faculty Medical Group
- University of California, San Francisco
For direct contact, visit the study record on ClinicalTrials.gov .