The Effect of Tranexamic Acid for Total Hip Arthroplasty

Phase 4

• Conditions: Hemorrhage
• Interventions: Drug: serum physiologic; Drug: tranexamic acid

• Registration Number: NCT02094066
• Lead Sponsor: TC Erciyes University

Brief Summary

The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.

Detailed Description

Orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.Transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. Measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. Blood banks regularly undergo blood shortages. For these reasons, there is a need to reduce allogeneic blood transfusions. A number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. Pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (EACA) could reduce perioperative blood loss by interfering with fibrinolysis.

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-20
• Study First Posted: 2014-03-21
• Last Update Submitted: 2014-03-24
• Last Update Posted: 2014-03-26
• Primary Completion: 2014-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA 2-3
• 18-75 age
• total hip arthroplasty surgery
• regional anesthesia

Exclusion Criteria

• allergies to drug
• liver and kidney failure
• ischemic heart disease
• coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
serum physiologic	serum physiologic	preoperative 100 cc serum physiologic
tranexamic acid	tranexamic acid	preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes

Primary Outcome Measures

Name	Time	Method
hemorrhage	intraoperative	the amount of bleeding in aspirator and sponges

Secondary Outcome Measures

Name	Time	Method
erythrocyte transfusion	intraoperative and postoperative 3 days

Trial Locations

Locations (1)

Erciyes univercity medicine faculty; 🇹🇷 Kayseri, Turkey