Overview

This trial is active, not recruiting.

Condition hip fracture
Treatment tranexamic acid
Phase phase 4
Sponsor Mayo Clinic
Start date September 2012
End date October 2015
Trial size 152 participants
Trial identifier NCT01714336, 12-004599

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
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 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
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.

Primary Outcomes

Measure
Hospitalization transfusion
time frame: 5 days

Secondary Outcomes

Measure
Total number of units transfused
time frame: 5 days
Calculated blood loss
time frame: 5 days
Venous Thromboembolism (VTE) diagnosis
time frame: Within 6 months of surgery
Wound complications
time frame: Within 6 months of surgery
Myocardial infarction (MI) Diagnosis
time frame: Within 6 monhts of surgery
Cerebrovascular Accident (CVA) Diagnosis
time frame: Within 6 months of surgery
Mortality
time frame: 6 months after surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial
Principal investigator Mark Pagnano, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.