Clinical Trials Directory

Trials / Completed

CompletedNCT03656445

Tranexamic Acid in Total Knee Replacement

Multiple Intravenous Tranexamic Acid Doses Can Reduce Postoperative Blood Loss and Improve the Functional Outcome in Total Knee Arthroplasty Without Tourniquet: a Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
180 (actual)
Sponsor
Democritus University of Thrace · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Multiple intravenous Tranexamic Acid doses can reduce postoperative blood loss and improve the functional outcome in total knee arthroplasty without tourniquet: a randomized controlled study.

Detailed description

A total of 180 patients undergoing TKA for knee osteoarthritis were stratified in three equal groups. All surgeries were performed under spinal anesthesia, without tourniquet and patients should be in agreement with the established inclusion/exclusion criteria. Group A (60 patients) received 1g of IV TXA, Group B (60 patients) received an additional dose of IV TXA and Group C (60 patients) received three doses of IV TXA. The measured outcomes were the Hemoglobin (Hb) decrease, the transfusion rate, the functional, quality of life (QoL) and pain assessment based on their corresponding scoring system.

Conditions

Interventions

TypeNameDescription
DRUGTranexamic Acid1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia
DRUGTranexamic Acid1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision
DRUGTranexamic Acid1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectivel

Timeline

Start date
2015-10-01
Primary completion
2017-03-31
Completion
2017-03-31
First posted
2018-09-04
Last updated
2018-09-05

Source: ClinicalTrials.gov record NCT03656445. Inclusion in this directory is not an endorsement.