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

Phase 4

Completed

Conditions: Hip Fracture

Interventions: Drug: placebo
Drug: tranexamic acid

Registration Number: NCT01714336

Lead Sponsor: Mayo Clinic

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	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.
tranexamic acid	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Received a Hospitalization Transfusion	5 days	Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Cerebrovascular Accident (CVA) Diagnosis	Within 6 months of surgery	CVA diagnosed within 6 months of surgery
Number of Participants Who Died	6 months after surgery	All-cause mortality at 6 months
Number of Participants With Myocardial Infarction (MI) Diagnosis	Within 6 months of surgery	MI diagnosed within 6 months of surgery
Mean Number of Units Transfused	5 days	Mean number of units transfused per patient
Calculated Blood Loss	5 days	Calculated blood loss
Number of Participants With Venous Thromboembolism (VTE) Diagnosis	Within 6 months of surgery	Incidence of symptomatic VTE diagnosed within 6 months of surgery
Number of Participants With Wound Complications	Within 6 months of surgery	Wound complications diagnosed within 6 months of surgery