Oral Versus Intravenous Tranexamic Acid
Primary Purpose
Blood Loss, Blood Transfusion
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Sponsored by

About this trial
This is an interventional treatment trial for Blood Loss
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
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oral Tranexamic Acid (TXA)
Intravenous (IV) Tranexamic Acid (TXA)
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Time to Discharge From Physical Therapy
Time to discharge from physical therapy (in minutes)
Length of Stay
Hospital length of stay (in minutes)
Full Information
NCT ID
NCT04089865
First Posted
September 6, 2019
Last Updated
September 27, 2023
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT04089865
Brief Title
Oral Versus Intravenous Tranexamic Acid
Official Title
Blood Loss in Arthroplasty With Oral Versus IV Tranexamic Acid
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Blood Transfusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Tranexamic Acid (TXA)
Arm Type
Experimental
Arm 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.
Arm Title
Intravenous (IV) Tranexamic Acid (TXA)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Lysteda
Intervention Description
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.
Primary Outcome Measure Information:
Title
Calculated Blood Loss
Description
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.
Time Frame
post-operative day 0
Secondary Outcome Measure Information:
Title
Transfusion During Hospital Stay
Description
To assess how many participants required a blood transfusion during their hospital stay. This will be measured in binary responses (yes/no).
Time Frame
From Post-Operative Day 0 to Post-Operative Day 2
Title
Time to Discharge From Physical Therapy
Description
Time to discharge from physical therapy (in minutes)
Time Frame
From 48-72 hours after surgery
Title
Length of Stay
Description
Hospital length of stay (in minutes)
Time Frame
After surgery to the time discharged from hospital (estimated 48-72 hours after surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Memtsoudis, MD PhD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Certain individual participant data will be available. Individual participant data that underlie the results reported in a future article, after deidentification (text, tables, figures, appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal.
Learn more about this trial
Oral Versus Intravenous Tranexamic Acid
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