Corvallis, Oregon 97330


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

15-021


NCT ID:

NCT02580227


Secondary ID:


Study Acronym:


Brief Title:

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.


Overall Status:

Recruiting


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Good Samaritan Regional Medical Center, Oregon


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Stefan Yakel, DO
541-768-4810
styakel@samhealth.org
Backup Contact:Shawn Spooner
541-768-6349
sspooner@samhealth.org

Study Dates

Start Date:June 2015
Completion Date:March 2017
Completion Type:Anticipated
Primary Completion Date:August 2016
Primary Completion Type:Anticipated
Verification Date:October 2015
Last Changed Date:October 27, 2015
First Received Date:October 5, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Blood Transfusion Rates
Time Frame:Admission to discharge, 3-4 days on average.
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Perioperative Blood Loss
Time Frame:Admission to discharge, 3-4 days on average.
Safety Issues:True
Description:Perioperative blood loss measured by serial hemoglobin and hematocrit

Study Interventions

Intervention Type:Drug
Name:Tranexamic Acid
Description: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.
Arm Name:Tranexamic Acid
Intervention Type:Other
Name:Placebo
Description: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.
Arm Name:Placebo

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Patients will be randomized 1:1 onto active TXA arm, or placebo arm.
Study Arm Type:Active Comparator
Arm Name:Tranexamic Acid
Description:Patients will be randomized 1:1 onto active TXA arm, or placebo arm.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Good Samaritan Regional Medical Center, Oregon

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:25265109
Reference Type:Results Reference
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.
PMID:23381612
Reference Type:Results Reference
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. Epub .
PMID:19926634
Reference Type:Results Reference
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.
PMID:23717228

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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