Clinical trial NCT01714336: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Fracture
Keywords: Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture
Orthopaedic Trauma Association (OTA) fracture
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-10-25
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants Who Received a Hospitalization Transfusion
timeFrame: 5 days
Secondary outcomes:
measure: Mean Number of Units Transfused
timeFrame: 5 days
measure: Calculated Blood Loss
timeFrame: 5 days
measure: Number of Participants With Venous Thromboembolism (VTE) Diagnosis
timeFrame: Within 6 months of surgery
measure: Number of Participants With Wound Complications
timeFrame: Within 6 months of surgery
measure: Number of Participants With Myocardial Infarction (MI) Diagnosis
timeFrame: Within 6 months of surgery
measure: Number of Participants With Cerebrovascular Accident (CVA) Diagnosis
timeFrame: Within 6 months of surgery
measure: Number of Participants Who Died
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Pagnano, MD
role: PRINCIPAL_INVESTIGATOR
References: