Tranexamic Acid in Intertrochanteric and Subtrochanteric Femur Fractures

The Effect of Preoperative Tranexamic Acid on Blood Loss and Transfusion Rates in Intertrochanteric and Subtrochanteric Femur Fractures.

The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss and need for perioperative blood transfusion following intertrochanteric and subtrochanteric femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our hypothesis is that by providing TXA at the time of hospital admission it will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in which half of patients will be randomized to receive TXA at the time of hospital admission and half of patients will receive a placebo.

Study Overview

• Status: Unknown
• Conditions: Hip Fractures; Surgical Blood Loss
• Intervention / Treatment: Drug: Tranexamic Acid; Other: Placebo

Detailed Description

Tranexamic Acid has a long and proven history of clinical safety and effectiveness in the Orthopaedic literature. Its use in perioperative blood management in total joint arthroplasty is wide spread and is quickly becoming a standard of care. However, evidence on the effectiveness of TXA in lower extremity fracture care is more limited. There is a logical expectation that the use of TXA in lower extremity fracture care will provide a similar benefit in minimizing blood loss and reducing transfusion requirements, based on TXA's success in total joint arthroplasty, however this has not yet been validated in the literature. This study will seek to evaluate the effectiveness of TXA in perioperative blood management within a subset of lower extremity fracture, specifically intertrochanteric femur fractures. Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications. Intertrochanteric femur fractures have an increased risk of post-operative blood transfusion when compared to femoral neck fractures. It is presumed that the difference in blood loss between these two fracture types is caused by increased pre-operative bleeding of intertrochanteric fractures secondary to the extracapsular nature of the fracture, as opposed to a tamponade effect that occurs with intracapsular femoral neck fractures. It can therefore be expected that the use of TXA in intertrochanteric femur fractures will decrease perioperative bleeding leading to a decrease in total blood loss and a decrease in transfusion rates.

Limited research has shown that TXA is effective in reducing perioperative blood loss in hip fracture when compared to placebo, but not as effectively as when used in joint arthroplasty. One explanation for this difference is that TXA is circulating at the time of iatrogenic fracture in total joint arthroplasty or given shortly after, whereas intraoperative TXA administration in hip fractures usually doesn't occur until 6-48 hours after the initial injury. Administering TXA at the time of hospital admission in intertrochanteric femur fracture allows the drug time to decrease blood loss resulting from the fracture as well as the subsequent surgical intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Recruiting
      • Good Samaritan Hospital Corvallis
      • Contact: Stefan Yakel, DO; Phone Number: 541-768-4810; Email: styakel@samhealth.org
      • Contact: Shawn Spooner, BA; Phone Number: 541-768-6349; Email: sspooner@samhealth.org
      • Sub-Investigator: Jacqueline Krumrey, MD

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:

• Patients sustaining a closed intertrochanteric femur fracture presenting to the Good Samaritan Regional Medical Center.
• Patients who are willing and able to consent to participate in the study
• >18 years of age

Exclusion Criteria:

• Patients with an allergy to tranexamic acid.
• History of thromboembolic event (pulmonary embolism, cerebral vascular accident, deep venous thrombosis),
• History of renal impairment (Cr > 1.5 or glomerular filtration rate < 30)
• Coronary stents
• History of hypercoagulability (Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant).
• Color blindness
• Subarachnoid hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic Acid; Patients will be randomized 1:1 onto active TXA arm, or placebo arm.	Drug: Tranexamic Acid; All subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given.
Placebo Comparator: Placebo; Patients will be randomized 1:1 onto active TXA arm, or placebo arm.	Other: Placebo; All subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative Blood Loss	Perioperative blood loss measured by serial hemoglobin and hematocrit	Admission to discharge, 3-4 days on average.
Blood Transfusion Rates		Admission to discharge, 3-4 days on average.

Other Outcome Measures

Outcome Measure	Time Frame
Calculated Blood Loss	Admission to discharge, 3-4 days on average.
Length of Stay	Admission to discharge, 3-4 days on average.
Myocardial Infarction	Admission to discharge, 3-4 days on average.
Deep Venous Thrombosis	Admission to discharge, 3-4 days on average.
Pulmonary Embolism	Admission to discharge, 3-4 days on average.
Cerebrovascular Accident	Admission to discharge, 3-4 days on average.
Surgical Site Infection Rate	Admission to discharge, 3-4 days on average.

Collaborators and Investigators

• Sponsor: Good Samaritan Regional Medical Center, Oregon

Publications and helpful links

General Publications

• Desai SJ, Wood KS, Marsh J, Bryant D, Abdo H, Lawendy AR, Sanders DW. Factors affecting transfusion requirement after hip fracture: can we reduce the need for blood? Can J Surg. 2014 Oct;57(5):342-8. doi: 10.1503/cjs.030413.
• Kadar A, Chechik O, Steinberg E, Reider E, Sternheim A. Predicting the need for blood transfusion in patients with hip fractures. Int Orthop. 2013 Apr;37(4):693-700. doi: 10.1007/s00264-013-1795-7. Epub 2013 Feb 5.
• Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.
• Vijay BS, Bedi V, Mitra S, Das B. Role of tranexamic acid in reducing postoperative blood loss and transfusion requirement in patients undergoing hip and femoral surgeries. Saudi J Anaesth. 2013 Jan;7(1):29-32. doi: 10.4103/1658-354X.109803.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 27, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Tranexamic Acid; Blood Transfusions
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Hip Injuries; Intraoperative Complications; Femoral Fractures; Hemorrhage; Fractures, Bone; Hip Fractures; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 15-021