Oral Versus Intravenous Tranexamic Acid

Blood Loss Clinical Trial

Official title:

Blood Loss in Arthroplasty With Oral Versus IV Tranexamic Acid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089865
• Other study ID #: 2019-0882
• Status: Completed
• Phase: Phase 4
• Start date: September 17, 2019
• Est. completion date: November 10, 2021

Study information

• Verified date: September 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss
• Blood Transfusion
• Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated Blood Loss	Calculated Blood loss (CBL) measured in mL, measured at baseline (before surgery) and in the post-operative care unit (after surgery). The following formula was used CBL = BV × (HctPre - HctPost), where BV = (k1 × H3) + (k2 × W) + k3. The variables for the formula are as followed: CBL: Calculated blood loss BV: Blood volume at baseline HctPre: Haematocrit before surgery HctPost: Haematocrit after surgery H: Patient height in meters W: Patient weight in kilograms; Although measured at two time points (before and after surgery), the calculated value from those two time points is average across all participants and reported.	post-operative day 0
Secondary	Transfusion During Hospital Stay	To assess how many participants required a blood transfusion during their hospital stay. This will be measured in binary responses (yes/no).	From Post-Operative Day 0 to Post-Operative Day 2
Secondary	Time to Discharge From Physical Therapy	Time to discharge from physical therapy (in minutes)	From 48-72 hours after surgery
Secondary	Length of Stay	Hospital length of stay (in minutes)	After surgery to the time discharged from hospital (estimated 48-72 hours after surgery)