Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study

NCT02806024 | Completed Phase 4 Results DMC

• 1 other identifier: 2016036
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta Accreta; Postpartum Hemorrhage; Cesarean Section; Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood Transfusion (Number of Units Transfused) Intraoperatively

  Pulled from operative note, completed by the time of discharge.

Study Arms (2)

Treatment Arm (Tranexamic Acid, or TXA)

EXPERIMENTAL

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 Arm

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid DRUG

Treatment Arm (Tranexamic Acid, or TXA)

Placebo Drug DRUG

50 cc Normal Saline IV

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Central California Faculty Medical Group: collaborator

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93721, United States

Location

Related Publications (3)

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

  PMID: 26079202 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000219750.79480.84.

  PMID: 16738145 BACKGROUND

• Abdel-Aleem H, Alhusaini TK, Abdel-Aleem MA, Menoufy M, Gulmezoglu 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.

  PMID: 23574458 BACKGROUND

MeSH Terms

Conditions

Placenta Accreta; Postpartum Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Mallory Kremer
• Organization: University of Washington

mkremer@uw.edu

206.616.5258

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Clinical Instructor

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 20, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)