deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT02806024

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

Updated 10 times since 2017 Last updated: Nov 14, 2019 Started: Nov 30, 2016 Primary completion: Jul 31, 2018 Completion: Aug 31, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotRecruiting~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotRecruiting~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshotRecruiting~Apr 2019 – ~Jan 2020 · 9 months · monthly snapshotCompleted~Jan 2020 – ~Jan 2021 · 12 months · monthly snapshotCompleted~Jan 2021 – ~Feb 2023 · 25 months · monthly snapshotCompleted~Feb 2023 – ~Jul 2024 · 17 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Present [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Feb 2023 — Jul 2024 [monthly]

    Completed PHASE4

  5. Jan 2021 — Feb 2023 [monthly]

    Completed PHASE4

Show 5 earlier versions
  1. Jan 2020 — Jan 2021 [monthly]

    Completed PHASE4

  2. Apr 2019 — Jan 2020 [monthly]

    Completed PHASE4

    Status: RecruitingCompleted

  3. Jun 2018 — Apr 2019 [monthly]

    Recruiting PHASE4

  4. Feb 2017 — Jun 2018 [monthly]

    Recruiting PHASE4

  5. 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

Sponsor contact:
  • Central California Faculty Medical Group
  • University of California, San Francisco
Data source: University of California, San Francisco

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations