Efficacy of Intravenous Versus Topical Tranexamic Acid in Primary Total Hip Arthroplasty (TeACH-R)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Lawson Health Research Institute
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Douglas Naudie, London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02056444
First received: February 3, 2014
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

Bleeding during and after total hip replacement surgery is a primary concern to the surgical and anaesthetic team. Tranexamic acid is a commonly-used drug that helps blood clotting and decreases surgical bleeding. The investigators commonly administer the drug intravenously prior to the procedure. Some patients are unable to receive the drug in this form, because of risks related to blood clotting. The investigators know, from studies in total knee replacement surgery, that the investigators can deliver tranexamic acid directly to the surgical site (topically), with similar benefits and less of the drug absorbed into the bloodstream, resulting in less risk to the patient. The investigators seek to find if similar benefit in terms of reducing blood loss is seen using topical tranexamic acid in hip replacement surgery. The investigators' hypothesis is that the topical form will be equivalent, but not better than the intravenous form for reducing intra- and postoperative bleeding. The investigators also expect to see decreased levels of tranexamic acid in the bloodstream when it is administered topically.


Condition Intervention
Osteoarthritis
Drug: Tranexamic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid Comparison in Hip Replacement (TeACH-R) Trial: Comparative Efficacy of Intravenous Versus Topical Tranexamic Acid for Reducing Blood Loss in Elective Primary Total Hip Arthroplasty.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Delta-hemoglobin (ΔHgb) [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA) ] [ Designated as safety issue: No ]
    (Measured Hgb value closest to operative date) - (lowest Hgb value measured postoperatively in hospital)

  • Calculated blood loss [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA) ] [ Designated as safety issue: No ]
    Based on difference between preoperative and postoperative Hgb and hematocrit (Hct) levels.


Secondary Outcome Measures:
  • Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism) [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up. ] [ Designated as safety issue: Yes ]
    Clinically proven symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE).

  • Acute coronary syndrome [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up. ] [ Designated as safety issue: Yes ]
  • Cerebrovascular accident (stroke) [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up. ] [ Designated as safety issue: Yes ]
  • Acute kidney injury (AKI) [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up. ] [ Designated as safety issue: Yes ]
  • Pneumonia [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up. ] [ Designated as safety issue: Yes ]
    Radiographically-proven pneumonia.

  • Other systemic illness/infection [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up. ] [ Designated as safety issue: Yes ]
    To be specified on the data collection form.

  • Number of units of packed red blood cell transfused [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA) ] [ Designated as safety issue: Yes ]
  • Hematoma [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA); 2 week follow-up; 6 week follow-up; 3 month follow-up. ] [ Designated as safety issue: Yes ]
    Presence of post-operative hematoma near the surgical wound

  • Length of stay in hospital (days) [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA) ] [ Designated as safety issue: No ]
    Length of hospital stay after total hip arthroplasty

  • Systemic serum tranexamic acid (TXA) levels [ Time Frame: One hour after administration of TXA ] [ Designated as safety issue: No ]
    Blood sample collected one hour after administration, both for the topical and intravenous routes.


Estimated Enrollment: 144
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical tranexamic acid (TXA)
Single dose 1.5 grams topical TXA infiltrated into the surgical field at time of arthrotomy closure.
Drug: Tranexamic Acid
Other Name: Cyclokapron
Active Comparator: Intravenous TXA
Single 20 mg/kg dose of intravenous TXA administered prior to skin incision.
Drug: Tranexamic Acid
Other Name: Cyclokapron

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary elective total hip arthroplasty
  • Cementless total hip implant system
  • Candidate for administration of TEA (as per the LHSC Perioperative Blood Conservation Program Medical Directive titled Preoperative Written Order for Tranexamic Acid in Orthopaedic Surgery)
  • Fitness for surgery confirmed after Pre-Admission Clinic appointment
  • Consent for transfusion of blood or blood-related products obtained at time of Pre-Admission Clinic appointment.
  • Ability to read and understand the English language

Exclusion Criteria:

  • Not deemed medically fit for major orthopaedic surgery
  • Revision total hip arthroplasty
  • Non-elective indication for total hip arthroplasty
  • History of thrombotic vascular event (VTE) in the previous 12 months, or requiring lifelong anticoagulation related to previous VTE. VTE is defined as cerebrovascular event (stroke, transient ischemic attack), deep vein thrombosis, and pulmonary embolism
  • Consent for transfusion of blood or blood-related products not obtained
  • History of developmental hip dysplasia in the operative hip
  • History of Legg-Calve-Perthes disease in the operative hip
  • Documented allergy to TEA, or to any of its constituent agents
  • Unable to participate in scheduled follow-up appointments.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056444

Contacts
Contact: Katherine Hrabok, BHSc, RMT 519-685-8500 ext 32794 katherine.hrabok@lhsc.on.ca
Contact: Abigail Korczak, BScN 519-685-8500 ext 32789 abigail.korczak@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre, University Hospital Recruiting
London, Ontario, Canada, N5X0B7
Contact: Katherine Hrabok, BHSc, RMT    519-685-8500 ext 32794    katherine.hrabok@lhsc.on.ca   
Principal Investigator: Douglas DR Naudie, MD, FRCSC         
Principal Investigator: James L Howard, MD, MSc, FRCSC         
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
Principal Investigator: Douglas DR Naudie, MD, FRCSC The Joint Replacement Institute at London Health Sciences Centre, University Hospital
Principal Investigator: James L Howard, MD, MSc, FRCSC The Joint Replacement Institute at London Health Sciences Centre, University Hospital
Principal Investigator: Richard P Nadeau, BMSc, MD Western University and London Health Sciences Centre
  More Information

Publications:
Responsible Party: Douglas Naudie, Consultant Orthopaedic Surgeon, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02056444     History of Changes
Other Study ID Numbers: TeACH-R Trial
Study First Received: February 3, 2014
Last Updated: August 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Blood conservation
Tranexamic acid
Total hip arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014