Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT01714336
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Rochester, Minnesota, 55905, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 5 days
Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission
Time frame: 5 days
Mean number of units transfused per patient
Time frame: 5 days
Calculated blood loss
Time frame: Within 6 months of surgery
Incidence of symptomatic VTE diagnosed within 6 months of surgery
Time frame: Within 6 months of surgery
Wound complications diagnosed within 6 months of surgery
Time frame: Within 6 months of surgery
MI diagnosed within 6 months of surgery
Time frame: Within 6 months of surgery
CVA diagnosed within 6 months of surgery
Time frame: 6 months after surgery
All-cause mortality at 6 months
Mayo Clinic
Other
Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial
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