The Effect of Tranexamic Acid for Total Hip Arthroplasty

TC Erciyes University

Status and phase: Unknown; Phase 4

Conditions: Hemorrhage

Treatments: Drug: tranexamic acid; Drug: serum physiologic

Study type: Interventional

Funder types: Other

Identifiers

NCT02094066

2012/683

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups

tranexamic acid

Active Comparator group

Description:

preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes

Treatment:

Drug: tranexamic acid

serum physiologic

Sham Comparator group

Description:

preoperative 100 cc serum physiologic

Treatment:

Drug: serum physiologic