Effects of Tranexamic Acid on Blood Loss and Transfusion Requirement Following Hip Fracture

Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has been shown effective in decreasing blood loss both intra-operatively and in the immediate post-operative period in elective hip and knee arthroplasty patients. Both the timing and dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has also been shown to decrease as result of TA administration. Despite the support for TA utilization that exists in the arthroplasty literature, the data is scarce regarding its administration during surgical treatment of hip fractures. This is patient population who is at high risk for transfusion due to symptomatic post-operative anemia. This study aims to investigate whether TA's advantageous effects in the arthroplasty patient population can be extrapolated to the more unstable, heterogeneous hip fracture patient population. If the study is able to show a difference in blood loss and transfusion requirement, the long term implications of this with regards to cost and mortality can be significant.

Study Overview

• Status: Unknown
• Conditions: Hip Fracture
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Control: Saline

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Recruiting
      • Bryn Mawr Hospital

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 admitted to Bryn Mawr Hospital with fracture of the femoral neck, intertrochanteric region, or subtrochanteric region of the femur will be considered for the study.

Exclusion Criteria:

Exclusion criteria include

• age under 18
• allergy to TA
• known current or history of venous thromboembolism (VTE)
• history of known coagulopathy or bleeding disorder
• current subarachnoid hemorrhage
• previous history of seizures
• current use of estrogen/progesterone therapy
• renal failure defined as creatinine clearance less than 30 ml/min4
• multiple fractures
• pregnant or breastfeeding women
• planned nonoperative management of the fracture

Study Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Drug: Control: Saline
Active Comparator: Interventional	Drug: Tranexamic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
calculation of blood loss during the perioperative period	This study aims to investigate the effect of tranexamic acid (TA) on blood loss and transfusion requirement during the perioperative period in patients who are admitted to the hospital with fracture of the hip and undergo surgical treatment. Both the drop in hemoglobin level from time of surgery (T0 being defined as just prior to surgery, while the patient waits in surgical holding area) over the subsequent several days, as well as post-operative transfusion rate, will be measured. The researchers' hypothesis is that both the hemoglobin drop and the subsequent transfusion requirement in patients who receive TA will be less than those who received saline placebo.	participants will be followed for the duration of hospital stay, an expected average of 2-3 days

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Primary Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 8, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 14RGOOD01