Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean

NCT03364491 | Completed Phase 3 Results DMC FDA Drug

• 14 other identifiers: HD36801-TXAU10HD036801UG1HD087230UG1HD027869UG1HD040500UG1HD034208UG1HD027915UG1HD040485UG1HD053097UG1HD040544UG1HD040545UG1HD040560UG1HD040512UG1HD087192
• Study Type: interventional
• Target: 11,000
• Locations: 1 country
• Sites: 12

Brief Summary

A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.

Conditions

Obstetrical Complications; Hemorrhage; Labor and Delivery

Keywords

Tranexamic Acid; Hemorrhage; Cesarean

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Maternal Death or Transfusion of Packed Red Blood Cells

  Participants were monitored from delivery until hospital discharge or 7 days after delivery (postpartum), whichever is sooner. This is the number of mothers who died for any reason, or had a blood transfusion of 1 or more units (of packed red blood cells, including whole blood or cell saver).

  by hospital discharge or by 7 days postpartum, whichever is sooner

Secondary Outcomes (13)

• Number of Participants With Estimated Blood Loss Greater Than 1 Liter During Delivery

  From skin incision to transfer from operating room, average of 1 hour

• Number of Mothers Who Died or Had Thromboembolic Events (Venous or Arterial), Ischemic Stroke, Myocardial Infarction, New-onset Seizure Activity, or Were Admitted to the Intensive Care Unit for More Than 24 Hours

  within 6 weeks postpartum

• Number of Participants Who Were Transfused With Other Blood Products

  within 7 days postpartum

• Number of Participants Who Were Transfused With 4 or More Units of Packed Red Blood Cells

  within 7 days postpartum

• Number of Participants With a Thromboembolic Event (Venous or Arterial), Ischemic Stroke, or Myocardial Infarction

  within 6 weeks postpartum

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL

Tranexamic Acid for intravenous administration

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

Normal saline for intravenous administration

Drug: Placebo

Interventions

Tranexamic Acid DRUG

A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)

Also known as: TXA

Tranexamic Acid

Placebo DRUG

50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled or unscheduled cesarean delivery
• Singleton or twin gestation

You may not qualify if:

• Age less than 18 years
• Transfusion or planned transfusion of any blood products during the current admission because the primary outcome is already pre-determined and the need for transfusion will be unrelated to perioperative hemorrhage
• Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated
• Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis
• Seizure disorder (including eclampsia) because TXA is a GABA receptor antagonist, and its use has been associated with postoperative seizures
• Serum creatinine 1.2 or higher or on dialysis, with renal disease, or a history of renal insufficiency, because TXA is substantially excreted by the kidney, and impaired renal function may increase the risk of toxic reactions.
• Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease because of hypercoagulability and the increased risk of thrombosis or thromboembolism
• Need for therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA
• Treatment with clotting factor concentrates, because the risk of thrombosis may be increased with TXA
• Presence of frank hematuria, because the risk of ureteral obstruction in those with upper urinary tract bleeding may be increased with TXA
• Patient refusal of blood products because the primary outcome is then pre-determined
• Receipt of TXA; or planned or expected use of TXA prophylaxis
• Active cancer, because of risk of thromboembolism
• Congestive heart failure requiring treatment, because of risk of thrombosis
• History of retinal disease, because the risk of central retinal artery or vein obstruction may be increased with TXA

Sponsors & Collaborators

• The George Washington University Biostatistics Center: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (12)

University of Alabama - Birmingham

Birmingham, Alabama, 35233, United States

Location

Northwestern University-Prentice Hospital

Chicago, Illinois, 60611, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Case Western Reserve-MetroHealth

Cleveland, Ohio, 44109, United States

Location

Ohio State University Hospital

Columbus, Ohio, 43210, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown University

Providence, Rhode Island, 02905, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

University of Texas - Houston

Houston, Texas, 77030, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

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MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Principal Investigator, MFMU
• Organization: George Washington University Biostatistics Center

mfmudatasets@bsc.gwu.edu

301-881-9260

Study Officials

• Rebecca Clifton, Ph.D.

  The George Washington University Biostatistics Center

  PRINCIPAL INVESTIGATOR

• Monica Longo, MD

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  STUDY DIRECTOR

• Louis Pacheco, MD

  UTMB

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient nor the clinical staff will be aware of the treatment assignment. The TXA or placebo solutions will be prepared by the center research pharmacies.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive either TXA (1 gram \[10cc\] mixed with 40 cc of normal saline) administered intravenously or a placebo control of 50 cc of normal saline administered intravenously

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 6, 2017
• Study Start: March 15, 2018
• Primary Completion: July 24, 2021
• Study Completion: October 29, 2021
• Last Updated: February 21, 2023
• Results First Posted: January 19, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (12)