Tranexamic Acid in Intertrochanteric and Subtrochanteric Femur Fractures

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02580227
• Other study ID #: 15-021
• Status: Recruiting
• Phase: Phase 4
• First received: October 5, 2015
• Last updated: October 27, 2015
• Start date: June 2015
• Est. completion date: March 2017

Study information

• Verified date: October 2015
• Source: Good Samaritan Regional Medical Center, Oregon
• Contact: Stefan Yakel, DO
• Phone: 541-768-4810
• Email: styakel[@]samhealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Femoral Fractures
• Fractures, Bone
• Hemorrhage
• Hip Fractures
• Surgical Blood Loss

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Good Samaritan Hospital Corvallis	Corvallis	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Good Samaritan Regional Medical Center, Oregon

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Calculated Blood Loss		Admission to discharge, 3-4 days on average.	Yes
Other	Length of Stay		Admission to discharge, 3-4 days on average.	No
Other	Myocardial Infarction		Admission to discharge, 3-4 days on average.	Yes
Other	Deep Venous Thrombosis		Admission to discharge, 3-4 days on average.	Yes
Other	Pulmonary Embolism		Admission to discharge, 3-4 days on average.	Yes
Other	Cerebrovascular Accident		Admission to discharge, 3-4 days on average.	Yes
Other	Surgical Site Infection Rate		Admission to discharge, 3-4 days on average.	Yes
Primary	Perioperative Blood Loss	Perioperative blood loss measured by serial hemoglobin and hematocrit	Admission to discharge, 3-4 days on average.	Yes
Primary	Blood Transfusion Rates		Admission to discharge, 3-4 days on average.	Yes