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Use of Transexamic Acid in Hip Replacement

Sponsor
Samsung Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02587845
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
14
Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid (IV)
  • Drug: Tranexamic Acid (Topical)
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Use of Tranexamic Acid(TNA) in Preventing Blood Loss During and After Total Hip Arthroplasty
Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: IV group

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

Drug: Tranexamic Acid (IV)
IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB.
Other Names:
  • TXA

    		•
    Experimental: 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.

    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.
    Other Names:
  • TXA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bleeding [intraoperatively]

      Surgical bleeding

    Secondary Outcome Measures

    1. Total Transfusion [5days after surgery]

      Allogenic transfusion

    Other Outcome Measures

    1. Operation time [intraoperatively]

      surgical time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 135-700

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Study Director: Youn Soo Park, MD, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Youn-Soo Park, Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT02587845
    Other Study ID Numbers:
    • 2014-01-129
    First Posted:
    Oct 27, 2015
    Last Update Posted:
    Oct 27, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Youn-Soo Park, Professor, Samsung Medical Center
    total hip arthroplasty
    transexamic acid
    Additional relevant MeSH terms:
    Tranexamic Acid

    Study Results

    No Results Posted as of Oct 27, 2015