Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement

Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?

Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Intertrochanteric Fractures
• Intervention / Treatment: Drug: Placebo; Drug: Tranexamic Acid (TXA)

Detailed Description

The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• AO/OTA fracture classification 31A
• Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
• Low energy, isolated injury

Exclusion Criteria:

• Intracapsular hip fractures: AO/OTA fracture classification 31B-C
• Polytrauma patients
• Creatinine clearance less than 30 mL/min
• History of unprovoked 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 CVA, MI, or VTE within the previous 30 days
• Coronary stent placement within the previous 6 months
• Disseminated intravascular coagulation
• Intracranial hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic Acid Arm (TXA); Subjects will be treated with early administration of TXA in the Emergency Department	Drug: Tranexamic Acid (TXA); Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours; Other Names: Cyklokapron
Placebo Comparator: Control Arm; Subjects will be treated with a placebo in the Emergency Department	Drug: Placebo; Looks exactly like the study drug, but it contains no active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells	Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.	Length of hospitalization (approximately 3 to 5 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Units of Packed Red Blood Cells Transfused	Number of units of packed red blood cells transfused per patient	Length of hospitalization (approximately 3 to 5 days)
Calculated Blood Loss	Total blood loss per patient measured in milliliters (mL)	Length of hospitalization (approximately 3 to 5 days)
Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)	Number of subjects to experience symptomatic Venous Thromboembolism (VTE)	Within 6 months of surgery
Wound Complications	Number of subjects diagnosed with a wound complication	Within 6 months of surgery
(Myocardial Infarction) MI Diagnosed	Number of subjects diagnosed with a myocardial infarction	Within 6 months of surgery
Cerebrovascular Accident (CVA) Diagnosed	Number of subjects diagnosed with a cerebrovascular accident	Within 6 months of surgery
All-cause Mortality	Number of subject deaths	At 6 months after surgery

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): May 24, 2022
• Study Completion (Actual): May 24, 2022

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: June 7, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 16-004988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share IPD with other researchers that are outside of the primary listed researchers within the primary institution where the investigation is being performed. While we intend the share the overall results of the study through peer review, we do not have our institution's IRB approval to share individual participant data outside of the institution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No