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Completed

NCT Number: NCT01714336

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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.

Placebo

Drug

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.

Primary outcomes

  1. Number of Participants Who Received a Hospitalization Transfusion

    Time frame: 5 days

    Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission

Secondary outcomes

  1. Mean Number of Units Transfused

    Time frame: 5 days

    Mean number of units transfused per patient

  2. Calculated Blood Loss

    Time frame: 5 days

    Calculated blood loss

  3. Number of Participants With Venous Thromboembolism (VTE) Diagnosis

    Time frame: Within 6 months of surgery

    Incidence of symptomatic VTE diagnosed within 6 months of surgery

  4. Number of Participants With Wound Complications

    Time frame: Within 6 months of surgery

    Wound complications diagnosed within 6 months of surgery

  5. Number of Participants With Myocardial Infarction (MI) Diagnosis

    Time frame: Within 6 months of surgery

    MI diagnosed within 6 months of surgery

  6. Number of Participants With Cerebrovascular Accident (CVA) Diagnosis

    Time frame: Within 6 months of surgery

    CVA diagnosed within 6 months of surgery

  7. Number of Participants Who Died

    Time frame: 6 months after surgery

    All-cause mortality at 6 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2012
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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