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

Primary Purpose

Hip Fracture

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tranexamic acid
placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fracture focused on measuring Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture, Orthopaedic Trauma Association (OTA) fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

tranexamic acid

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants Who Received a Hospitalization Transfusion
Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2012
Last Updated
November 12, 2018
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01714336
Brief Title
Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery?
Official Title
Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture, Orthopaedic Trauma Association (OTA) fracture

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
tranexamic acid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
tranexamic acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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 Outcome Measure Information:
Title
Number of Participants Who Received a Hospitalization Transfusion
Description
Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Mean Number of Units Transfused
Description
Mean number of units transfused per patient
Time Frame
5 days
Title
Calculated Blood Loss
Description
Calculated blood loss
Time Frame
5 days
Title
Number of Participants With Venous Thromboembolism (VTE) Diagnosis
Description
Incidence of symptomatic VTE diagnosed within 6 months of surgery
Time Frame
Within 6 months of surgery
Title
Number of Participants With Wound Complications
Description
Wound complications diagnosed within 6 months of surgery
Time Frame
Within 6 months of surgery
Title
Number of Participants With Myocardial Infarction (MI) Diagnosis
Description
MI diagnosed within 6 months of surgery
Time Frame
Within 6 months of surgery
Title
Number of Participants With Cerebrovascular Accident (CVA) Diagnosis
Description
CVA diagnosed within 6 months of surgery
Time Frame
Within 6 months of surgery
Title
Number of Participants Who Died
Description
All-cause mortality at 6 months
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Pagnano, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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