Oral Versus IV TXA

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT04089865
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Actual Duration (Months): 25.8
• Patients Per Site Per Month: 15.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Loss; Blood Transfusion	Drug: Tranexamic Acid	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Blood Loss in Arthroplasty With Oral Versus IV Tranexamic Acid
• Actual Study Start Date: Sep 17, 2019
• Actual Primary Completion Date: Nov 10, 2021
• Actual Study Completion Date: Nov 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral Tranexamic Acid (TXA) 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.	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.
Active Comparator: Intravenous (IV) Tranexamic Acid (TXA) 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.	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.

Outcome Measures

Primary Outcome Measures

1. Calculated Blood Loss [Post-Operative Day 0, 1]

   Calculated blood loss (CBL) in cc, to be calculated according to Gao (PMID 26521781)

Secondary Outcome Measures

1. Transfusion during hospital stay [During length of hospital stay (estimated Post-Operative Day 1, 2)]

   Both binary yes/no and discrete volume transfused

2. Time to discharge from physical therapy [During length of hospital stay (estimated 48-72 hours after surgery)]

   Time to discharge from physical therapy (in hours)

3. Length of Stay [During length of hospital stay (estimated 48-72 hours after surgery)]

   Hospital length of stay (in hours)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: Stavros Memtsoudis, MD PhD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT04089865
• Other Study ID Numbers: 2019-0882
• First Posted: Sep 13, 2019
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Hemorrhage; Tranexamic Acid

Study Results

No Results Posted as of Mar 31, 2022