Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery?

Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial

Does tranexamic acid improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

Study Overview

• Status: Completed
• Conditions: Hip Fracture
• Intervention / Treatment: Drug: placebo; Drug: tranexamic acid

Detailed Description

Antifibrinolytic medications such as tranexamic acid, aprotinin, and aminocaproic acid have proven to be useful in decreasing blood loss and the proportion of patients who require transfusion after a number of surgical procedures. In orthopedic surgery, tranexamic acid (TXA) is the best studied of these medications and a recent Cochrane Database review determined that tranexamic acid was effective in decreasing perioperative bleeding and post-operative transfusion after elective hip replacement and knee replacement surgery. At Mayo Clinic Rochester, the routine administration of tranexamic acid has evolved over the past decade to become part of the typical protocol for more than 3,000 elective hip and knee replacement procedures each year. Recent administrative data provides fairly compelling evidence of the efficacy of tranexamic acid in decreasing transfusion at the Mayo Clinic Rochester practice with 2010 data showing 2% and 7% prevalence of transfusion in patients treated with tranexamic acid versus 18% and 33% prevalence in those knee and hip replacement patients, respectively, who were not treated with tranexamic acid. A recent analysis of the Mayo Clinic Rochester orthopedic practice showed that patients treated for hip fracture remain at substantial risk of perioperative transfusion (30% prevalence) after operative management. This raises the question as to whether tranexamic acid could improve the perioperative care of those patients treated surgically for hip fracture by decreasing the proportion of patients requiring transfusion and decreasing total perioperative bleeding.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• AO/OTA (Orthopedic Trauma Association) fracture classification 31B
• Surgically treated with either hemiarthroplasty or total hip arthroplasty
• Acute fracture treated within 72 hours of injury
• Low energy isolated injury
• Age greater than 18 years old

Exclusion Criteria

• Transfusion received during admission, prior to surgery
• Creatinine clearance less than 30 mL/min
• History of unprovoked Venous Thromboembolism (VTE) and/or recurrent VTE
• Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
• Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
• History of cerebrovascular accident (CVA), Myocardial infarction (MI), or VTE within the previous 30 days
• Coronary stent placement within the previous 6 months
• Disseminated intravascular coagulation
• Subarachnoid hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.	Drug: placebo; A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.
Active Comparator: tranexamic acid; Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.	Drug: tranexamic acid; Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Received a Hospitalization Transfusion	Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Number of Units Transfused	Mean number of units transfused per patient	5 days
Calculated Blood Loss	Calculated blood loss	5 days
Number of Participants With Venous Thromboembolism (VTE) Diagnosis	Incidence of symptomatic VTE diagnosed within 6 months of surgery	Within 6 months of surgery
Number of Participants With Wound Complications	Wound complications diagnosed within 6 months of surgery	Within 6 months of surgery
Number of Participants With Myocardial Infarction (MI) Diagnosis	MI diagnosed within 6 months of surgery	Within 6 months of surgery
Number of Participants With Cerebrovascular Accident (CVA) Diagnosis	CVA diagnosed within 6 months of surgery	Within 6 months of surgery
Number of Participants Who Died	All-cause mortality at 6 months	6 months after surgery

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Mark Pagnano, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 25, 2012

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture; Orthopaedic Trauma Association (OTA) fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 12-004599