Oral Versus Intravenous Tranexamic Acid

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Blood Transfusion; Blood Loss

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04089865

2019-0882

Details and patient eligibility

About

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).

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing total hip arthroplasty (THA) through a posterior approach
• Patients undergoing total knee arthroplasty (TKA)
• Patients between 18-80 years of age

Exclusion criteria

• Patients with >80 years of age
• Patients with a BMI over 40
• Patients undergoing general anesthesia
• Patients with a history of major ipsilateral joint surgery
• Patients on pre-operative anticoagulation or anti-platelet drugs (other than aspirin)
• Patients with a history of bleeding disorders
• Patients with platelets less than 100/nl
• Patients with new-onset/active atrial fibrillation
• Patients with a history of myocardial infarction in the past year
• Patients with a history of a stroke in the past year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Oral Tranexamic Acid (TXA)

Experimental group

Description:

100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1950 mg of oral TXA in the pre-operative area.

Treatment:

Drug: Tranexamic Acid

Intravenous (IV) Tranexamic Acid (TXA)

Active Comparator group

Description:

100 Total Hip Arthroplasty (THA) and 100 Total Knee Arthroplasty (TKA) patients will be randomized to receive 1 g of intravenous (IV) TXA upon transfer to the operating room.

Treatment:

Drug: Tranexamic Acid