Oral Versus Intravenous Tranexamic Acid

NCT04089865 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019-0882
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Blood Loss; Blood Transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Transfusion During Hospital Stay

  From Post-Operative Day 0 to Post-Operative Day 2

• Time to Discharge From Physical Therapy

  From 48-72 hours after surgery

• Length of Stay

  After surgery to the time discharged from hospital (estimated 48-72 hours after surgery)

Study Arms (2)

Oral Tranexamic Acid (TXA)

EXPERIMENTAL

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

Intravenous (IV) Tranexamic Acid (TXA)

ACTIVE COMPARATOR

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

Interventions

Tranexamic Acid DRUG

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.

Also known as: Lysteda

Intravenous (IV) Tranexamic Acid (TXA); Oral Tranexamic Acid (TXA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing total hip arthroplasty (THA) through a posterior approach
• Patients undergoing total knee arthroplasty (TKA)
• Patients between 18-80 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Stavros G. Memtsoudis, MD, PhD, MBA
• Organization: Hospital for Special Surgery

memtsoudiss@hss.edu

(212) 606-1206

Study Officials

• Stavros Memtsoudis, MD PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 13, 2019
• Study Start: September 17, 2019
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: December 27, 2024
• Results First Posted: June 1, 2023

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal.

Locations

US (1)