The Effect of Tranexamic Acid for Total Hip Arthroplasty

Hemorrhage Clinical Trial

Official title:

The Effects of High Doze Tranexamic Acid Application on Hemorrhage, Blood Transfusion, Fibrin Degradation Products, and Kidney Functions for Total Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02094066
• Other study ID #: 2012/683
• Status: Recruiting
• Phase: Phase 4
• First received: March 19, 2014
• Last updated: March 24, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: March 2014
• Source: TC Erciyes University
• Contact: seher orbay yasli, resident
• Phone: +905052401933
• Email: sehersin81[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Drug:
• tranexamic acid
preoperative iv 50 mg/kg tranexamic acid infusion at 45 minutes
• serum physiologic
preoperative 100 cc iv serum physiologic

Locations

Country	Name	City	State
Turkey	Erciyes univercity medicine faculty	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemorrhage	the amount of bleeding in aspirator and sponges	intraoperative	No
Secondary	erythrocyte transfusion		intraoperative and postoperative 3 days	No