Phase 4 N=400 Randomized Treatment

Oral Versus Intravenous Tranexamic Acid

Blood Loss · Blood Transfusion

Bottom Line

View on ClinicalTrials.gov: NCT04089865 ↗

Enrolled (actual)

400

Serious AEs

0.3%

Results posted

Jun 2023

Primary outcome: Primary: Calculated Blood Loss — 842; 860; 799; 878 CBL (ml)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tranexamic Acid (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Calculated Blood Loss	842; 860; 799; 878	—
SECONDARY Transfusion During Hospital Stay	0; 0; 0; 1	—
SECONDARY Time to Discharge From Physical Therapy	2091.33; 1914.45; 2244.55; 2285.09	—
SECONDARY Length of Stay	2551.89; 2138.6; 2692.98; 2852.55	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04089865). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.