Clinical trial NCT04089865: Oral Versus Intravenous Tranexamic Acid
Official title: Blood Loss in Arthroplasty With Oral Versus IV Tranexamic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Loss
Blood Transfusion
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Calculated Blood Loss
timeFrame: post-operative day 0
Secondary outcomes:
measure: Transfusion During Hospital Stay
timeFrame: From Post-Operative Day 0 to Post-Operative Day 2
measure: Time to Discharge From Physical Therapy
timeFrame: From 48-72 hours after surgery
measure: Length of Stay
timeFrame: After surgery to the time discharged from hospital (estimated 48-72 hours after surgery)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Stavros Memtsoudis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: