Clinical trial NCT02580227: Tranexamic Acid in Intertrochanteric and Subtrochanteric Femur Fractures
Official title: The Effect of Preoperative Tranexamic Acid on Blood Loss and Transfusion Rates in Intertrochanteric and Subtrochanteric Femur Fractures.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hip Fractures
Surgical Blood Loss
Keywords: Tranexamic Acid
Blood Transfusions
Lead sponsor: Good Samaritan Regional Medical Center, Oregon
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perioperative Blood Loss
timeFrame: Admission to discharge, 3-4 days on average.
measure: Blood Transfusion Rates
timeFrame: Admission to discharge, 3-4 days on average.
Secondary outcomes:
Other outcomes:
measure: Calculated Blood Loss
timeFrame: Admission to discharge, 3-4 days on average.
measure: Length of Stay
timeFrame: Admission to discharge, 3-4 days on average.
measure: Myocardial Infarction
timeFrame: Admission to discharge, 3-4 days on average.
measure: Deep Venous Thrombosis
timeFrame: Admission to discharge, 3-4 days on average.
measure: Pulmonary Embolism
timeFrame: Admission to discharge, 3-4 days on average.
measure: Cerebrovascular Accident
timeFrame: Admission to discharge, 3-4 days on average.
measure: Surgical Site Infection Rate
timeFrame: Admission to discharge, 3-4 days on average.
Locations:
city: Corvallis
country: United States
facility: Good Samaritan Hospital Corvallis
state: Oregon
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.