Efficacy of Intravenous Versus Topical Tranexamic Acid in Primary Total Hip Arthroplasty (TeACH-R)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02056444 |
Recruitment Status :
Completed
First Posted : February 6, 2014
Last Update Posted : March 10, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis | Drug: Tranexamic Acid | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 149 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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. |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | February 2016 |
Actual Study Completion Date : | February 2016 |

Arm | Intervention/treatment |
---|---|
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 |
- Delta-hemoglobin (ΔHgb) [ Time Frame: POD0 to day of discharge (estimated time in hospital 2 to 5 days postop after primary THA) ](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) ]Based on difference between preoperative and postoperative Hgb and hematocrit (Hct) levels.
- 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. ]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. ]
- 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. ]
- 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. ]
- 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. ]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. ]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) ]
- 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. ]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) ]Length of hospital stay after total hip arthroplasty
- Systemic serum tranexamic acid (TXA) levels [ Time Frame: One hour after administration of TXA ]Blood sample collected one hour after administration, both for the topical and intravenous routes.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056444
Canada, Ontario | |
London Health Sciences Centre, University Hospital | |
London, Ontario, Canada, N5X0B7 |
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 |
Responsible Party: | Douglas Naudie, Consultant Orthopaedic Surgeon, London Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT02056444 |
Other Study ID Numbers: |
TeACH-R Trial |
First Posted: | February 6, 2014 Key Record Dates |
Last Update Posted: | March 10, 2016 |
Last Verified: | March 2016 |
Blood conservation Tranexamic acid Total hip arthroplasty |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Tranexamic Acid |
Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |