Efficacy of Intravenous Versus Topical Tranexamic Acid in Primary Total Hip Arthroplasty

NCT02056444 | Completed

• 1 other identifier: TeACH-R Trial
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Keywords

Blood conservation; Tranexamic acid; Total hip arthroplasty

Outcome Measures

Primary Outcomes (2)

• Delta-hemoglobin (ΔHgb)

  (Measured Hgb value closest to operative date) - (lowest Hgb value measured postoperatively in hospital)

  POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA)

• Calculated blood loss

  Based on difference between preoperative and postoperative Hgb and hematocrit (Hct) levels.

  POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA)

Secondary Outcomes (10)

• Venous thromboembolic event (symptomatic deep vein thrombosis or pulmonary embolism)

  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.

• Acute coronary syndrome

  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.

• Cerebrovascular accident (stroke)

  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.

• Acute kidney injury (AKI)

  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.

• Pneumonia

  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.

Study Arms (2)

Topical tranexamic acid (TXA)

EXPERIMENTAL

Single dose 1.5 grams topical TXA infiltrated into the surgical field at time of arthrotomy closure.

Drug: Tranexamic Acid

Intravenous TXA

ACTIVE COMPARATOR

Single 20 mg/kg dose of intravenous TXA administered prior to skin incision.

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

Also known as: Cyclokapron

Intravenous TXA; Topical tranexamic acid (TXA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

London Health Sciences Centre, University Hospital

London, Ontario, N5X0B7, Canada

Location

Related Publications (4)

• Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intraoperative dose of tranexamic Acid for patients having primary hip or knee arthroplasty. Clin Orthop Relat Res. 2010 Jul;468(7):1905-11. doi: 10.1007/s11999-009-1217-8. Epub 2010 Jan 9.

  PMID: 20063079 BACKGROUND

• Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908.

  PMID: 24196467 BACKGROUND

• Imai N, Dohmae Y, Suda K, Miyasaka D, Ito T, Endo N. Tranexamic acid for reduction of blood loss during total hip arthroplasty. J Arthroplasty. 2012 Dec;27(10):1838-43. doi: 10.1016/j.arth.2012.04.024. Epub 2012 Jun 14.

  PMID: 22704229 BACKGROUND

• Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23.

  PMID: 23886406 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Orthopaedic Surgeon

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 6, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 10, 2016

Record last verified: 2016-03

Locations

CA (1)