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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Mark Pagnano, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01714336
First received: October 23, 2012
Last updated: February 6, 2014
Last verified: February 2014
  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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Mayo Clinic:

Primary Outcome Measures:
  • Hospitalization transfusion [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission


Secondary Outcome Measures:
  • Total number of units transfused [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Mean number of units transfused per patient

  • Calculated blood loss [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Calculated blood loss

  • Venous Thromboembolism (VTE) diagnosis [ Time Frame: Within 6 months of surgery ] [ Designated as safety issue: No ]
    Incidence of symptomatic VTE diagnosed within 6 months of surgery

  • Wound complications [ Time Frame: Within 6 months of surgery ] [ Designated as safety issue: No ]
    Wound complications diagnosed within 6 months of surgery

  • Myocardial infarction (MI) Diagnosis [ Time Frame: Within 6 monhts of surgery ] [ Designated as safety issue: No ]
    MI diagnosed within 6 months of surgery

  • Cerebrovascular Accident (CVA) Diagnosis [ Time Frame: Within 6 months of surgery ] [ Designated as safety issue: No ]
    CVA diagnosed within 6 months of surgery

  • Mortality [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    All-cause mortality at 6 months


Estimated Enrollment: 152
Study Start Date: September 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714336

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Chad D. Watts, M.D.    507-284-2511    ORCU@mayo.edu   
Contact: Mark W. Pagnano, M.D.    507-284-2511    ORCU@mayo.edu   
Sub-Investigator: Chad D. Watts, M.D.         
Principal Investigator: Mark W. Pagnano, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Mark Pagnano, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Mark Pagnano, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01714336     History of Changes
Other Study ID Numbers: 12-004599
Study First Received: October 23, 2012
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
AO fracture
OTA fracture

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

ClinicalTrials.gov processed this record on September 15, 2014