Tranexamic Acid in Intertrochanteric and Subtrochanteric Femur Fractures
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic, Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | March 2017 |
| Contact: | Stefan Yakel, DO |
| Email: | styakel@samhealth.org |
| Phone: | 541-768-4810 |
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.
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.
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.
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.
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
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