Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study

Cesarean Section Clinical Trial

— TAPPAS  

Official title:

Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized, Placebo-controlled Double Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806024
• Other study ID #: 2016036
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: November 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cesarean Section
• Hemorrhage
• Placenta Accreta
• Placenta Previa
• Postpartum Hemorrhage
• Tranexamic Acid

Intervention

Drug:
• Tranexamic Acid

• Placebo Drug
50 cc Normal Saline IV

Locations

Country	Name	City	State
United States	Community Regional Medical Center	Fresno	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Central California Faculty Medical Group, University of California, San Francisco Fresno

Country where clinical trial is conducted

United States, 

References & Publications (3)

Abdel-Aleem H, Alhusaini TK, Abdel-Aleem MA, Menoufy M, Gülmezoglu AM. Effectiveness of tranexamic acid on blood loss in patients undergoing elective cesarean section: randomized clinical trial. J Matern Fetal Neonatal Med. 2013 Nov;26(17):1705-9. doi: 10.3109/14767058.2013.794210. Epub 2013 May 10. — View Citation

Novikova N, Hofmeyr GJ, Cluver C. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2015 Jun 16;(6):CD007872. doi: 10.1002/14651858.CD007872.pub3. Review. — View Citation

Silver RM, Landon MB, Rouse DJ, Leveno KJ, Spong CY, Thom EA, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal morbidity associated with multiple repeat cesarean deliveries. Obstet Gynecol. 2006 Jun;107(6):1226-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Blood Loss (EBL)	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	Blood Transfusion (Number of Units Transfused) Intraoperatively	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.