NCT04089865

Oral Versus Intravenous Tranexamic Acid

Blood Loss in Arthroplasty With Oral Versus IV Tranexamic Acid

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized clinical control trial is to determine whether oral TXA dosing in THA/TKA result in more blood loss and more transfusions compared to IV TXA dosing in patients undergoing THA/TKA under neuraxial anesthesia. The main questions it aims to answer are: Does oral TXA dosing in THA/TKA result in more blood loss compared to IV TXA dosing? Does oral TXA dosing in THA/TKA result in more transfusions compared to IV TXA dosing? Participants will be randomly assigned to either get the Oral TXA (1950mg) or the IV TXA (1g) on their day of surgery. Researchers will compare these groups to see if any differences emerged. 200 THA patients (100 Oral, 100 IV), 200 TKA patients (100 oral, 100 IV).

Detailed description

Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. The use of TXA in total hip arthroplasty (THA) and total knee arthroplasty (TKA) has resulted in dramatic decreases in operative blood loss and transfusion rates, revolutionizing the field of arthroplasty. The use of TXA, now common, has made autologous blood donation programs largely obsolete. Additionally, it has made perioperative blood transfusion uncommon. While AAOS guidelines suggest that all three available preparations of TXA (oral, IV, topical) are effective, preferred route of dosing varies by provider and institution. These preferences are based on habit, understanding of pharmacodynamics, and logistical issues regarding effective dosing. Oral TXA is the cheapest option, but some surgeons prefer IV dosing due to concerns regarding efficacy and controlled dosing. In this study, we seek to compare the efficacy of a single pre-op oral dose of TXA to a single pre-op IV dose of TXA.

Conditions

• Blood Loss
• Blood Transfusion

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.

Timeline

• Start date: 2019-09-17
• Primary completion: 2021-11-10
• Completion: 2021-11-10
• First posted: 2019-09-13
• Last updated: 2024-12-27
• Results posted: 2023-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study