Tranexamic Acid in Intertrochanteric and Subtrochanteric Femur Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hip Fractures Surgical Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tranexamic Acid

Patients will be randomized 1:1 onto active TXA arm, or placebo arm.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

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

Patients will be randomized 1:1 onto active TXA arm, or placebo arm.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No