Use of Transexamic Acid in Hip Replacement

NCT ID: NCT02587845

Last Updated: 2015-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-12-31

Brief Summary

Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. However, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary THA.

Detailed Description

Treatment of choice for osteoarthritis of the hip, developmental dysplasia of the hip, and osteonecrosis of the femoral head in older patients. In association with the investigators aging society, the number of patients who will need THA may increase significantly in the next few years [1]. However, in THA, considerable blood loss remains a major problem, which can lead to a need for allogeneic blood transfusion. Such 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, transfusion-related acute lung injury, intravascular hemolysis, transfusion-induced coagulopathy, renal failure, admission to intensive care, and even death. Several effective interventions have been developed to reduce blood loss and postoperative transfusion rates, such as preoperative autologous donation, cell salvage, controlled hypotension, regional anesthesia, and the use of erythropoietin and antifibrinolytics. The antifibrinolytics include aprotinin, tranexamic acid (TXA), and ε-aminocaproic acid, which have different mechanisms of action [8]. TXA is a synthetic derivative of the amino acid lysine and a competitive inhibitor of plasminogen activation, and thus interferes with fibrinolysis. Compared with other antifibrinolytic drugs, TXA is cheaper and safer than aprotinin and more potent than the others. Numerous studies have evaluated the use of antifibrinolytics in orthopedic surgery and have shown them to be effective in reducing blood loss. However, the available clinical trials and meta-analyses lack sufficient statistical power to determine the effectiveness of antifibrinolytic agents in total hip arthroplasty.

Conditions

Bleeding; Transfusion Related Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

IV group

Intravenous tranexamic acid injection Group IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid (IV)

Intervention Type: DRUG

IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB.

Topical group

Intra-articular tranexamic acid injection Group Topical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB.

Group Type: EXPERIMENTAL

Tranexamic Acid (Topical)

Intervention Type: DRUG

Topical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB.

Interventions

Tranexamic Acid (IV)

IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB.

Intervention Type: DRUG

Tranexamic Acid (Topical)

Topical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB.

Intervention Type: DRUG

Other Intervention Names

TXA; TXA

Eligibility Criteria

Inclusion Criteria

• Unilateral primary THA
• Diagnosis - not fracture, elective surgery
• Revision THA

Exclusion Criteria

• Known allergy to TNA
• Acquired or congenital coagulopathy
• Current anticoagulation therapy
• Preoperative hepatic or renal dysfunction
• Severe ischemic heart disease (Serious cardiac or respiratory disease)
• A history of thromboembolic disease
• Refusal of blood products
• Pregnancy or breastfeeding

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Youn-Soo Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Youn Soo Park, MD

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Facility Contacts

Youn-Soo Park, MD

Role: primary

82-2-3410-3509

Other Identifiers

2014-01-129

Identifier Type: -

Identifier Source: org_study_id