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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01714336
First Posted: October 25, 2012
Last Update Posted: May 16, 2016
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.
Information provided by (Responsible Party):
Mark Pagnano, Mayo Clinic
  Purpose
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.

Condition Intervention Phase
Hip Fracture Drug: tranexamic acid Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mark Pagnano, Mayo Clinic:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Mean Number of Units Transfused [ Time Frame: 5 days ]
    Mean number of units transfused per patient

  • Calculated Blood Loss [ Time Frame: 5 days ]
    Calculated blood loss

  • 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

  • Number of Participants With Wound Complications [ Time Frame: Within 6 months of surgery ]
    Wound complications diagnosed within 6 months of surgery

  • Number of Participants With Myocardial Infarction (MI) Diagnosis [ Time Frame: Within 6 months of surgery ]
    MI diagnosed within 6 months of surgery

  • Number of Participants With Cerebrovascular Accident (CVA) Diagnosis [ Time Frame: Within 6 months of surgery ]
    CVA diagnosed within 6 months of surgery

  • Number of Participants Who Died [ Time Frame: 6 months after surgery ]
    All-cause mortality at 6 months


Enrollment: 138
Study Start Date: September 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01714336


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Pagnano, MD Mayo Clinic
  More Information

Responsible Party: Mark Pagnano, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01714336     History of Changes
Other Study ID Numbers: 12-004599
First Submitted: October 23, 2012
First Posted: October 25, 2012
Results First Submitted: April 8, 2016
Results First Posted: May 16, 2016
Last Update Posted: May 16, 2016
Last Verified: April 2016

Keywords provided by Mark Pagnano, Mayo Clinic:
Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture
Orthopaedic Trauma Association (OTA) fracture

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants