Clinical trial NCT02587845: Use of Transexamic Acid in Hip Replacement
Official title: Use of Tranexamic Acid(TNA) in Preventing Blood Loss During and After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bleeding
Transfusion Related Complication
Keywords: total hip arthroplasty
transexamic acid
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Bleeding
timeFrame: intraoperatively
Secondary outcomes:
measure: Total Transfusion
timeFrame: 5days after surgery
Other outcomes:
measure: Operation time
timeFrame: intraoperatively
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Youn Soo Park, MD
role: STUDY_DIRECTOR
References: