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

Hip Fracture Clinical Trial

Official title:

Is Tranexamic Acid Effective in Limiting Transfusion After Hip Replacement for Femoral Neck Fracture: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714336
• Other study ID #: 12-004599
• Status: Completed
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Drug:
• 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.
• placebo
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Received a Hospitalization Transfusion	Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission	5 days
Secondary	Mean Number of Units Transfused	Mean number of units transfused per patient	5 days
Secondary	Calculated Blood Loss	Calculated blood loss	5 days
Secondary	Number of Participants With Venous Thromboembolism (VTE) Diagnosis	Incidence of symptomatic VTE diagnosed within 6 months of surgery	Within 6 months of surgery
Secondary	Number of Participants With Wound Complications	Wound complications diagnosed within 6 months of surgery	Within 6 months of surgery
Secondary	Number of Participants With Myocardial Infarction (MI) Diagnosis	MI diagnosed within 6 months of surgery	Within 6 months of surgery
Secondary	Number of Participants With Cerebrovascular Accident (CVA) Diagnosis	CVA diagnosed within 6 months of surgery	Within 6 months of surgery
Secondary	Number of Participants Who Died	All-cause mortality at 6 months	6 months after surgery