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Use of Transexamic Acid in Hip Replacement

Use of Tranexamic Acid(TNA) in Preventing Blood Loss During and After Total Hip Arthroplasty

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02587845
Enrollment
150
Registered
2015-10-27
Start date
2015-10-31
Completion date
2016-12-31
Last updated
2015-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Transfusion Related Complication

Keywords

total hip arthroplasty, transexamic acid

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.

Interventions

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

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

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
BleedingintraoperativelySurgical bleeding

Secondary

MeasureTime frameDescription
Total Transfusion5days after surgeryAllogenic transfusion

Other

MeasureTime frameDescription
Operation timeintraoperativelysurgical time

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026