CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 400 enrolled
Drug / intervention
Tranexamic Aciddrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04089865
NCT04089865Phase 4Completed

Blood Loss in Arthroplasty With Oral Versus IV Tranexamic Acid

Hospital for Special Surgery, New York·interventional·Posted Sep 13, 2019·Updated Dec 27, 2024

In Brief

A Phase 4 clinical trial evaluating Tranexamic Acid for Blood Loss and Blood Transfusion. Completed, enrolled 400 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedSep 13, 2019
Enrollment StartSep 17, 2019
Primary CompletionNov 10, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.8 years ago

Interventions

Tranexamic Aciddrug

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.