Effects of Tranexamic Acid on Blood Loss and Transfusion Requirement Following Hip Fracture

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Hip Fracture

Treatments: Drug: Tranexamic Acid; Drug: Control: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02738073

14RGOOD01

Details and patient eligibility

About

Tranexamic acid (TA) inhibits fibrinolysis by binding to lysine binding-sites of plasminogen to fibrin. Fibrinolysis is stimulated by surgical trauma, and the administration of TA has been shown effective in decreasing blood loss both intra-operatively and in the immediate post-operative period in elective hip and knee arthroplasty patients. Both the timing and dosing of TA has been investigated in these patients. Subsequent blood transfusion rate has also been shown to decrease as result of TA administration. Despite the support for TA utilization that exists in the arthroplasty literature, the data is scarce regarding its administration during surgical treatment of hip fractures. This is patient population who is at high risk for transfusion due to symptomatic post-operative anemia. This study aims to investigate whether TA's advantageous effects in the arthroplasty patient population can be extrapolated to the more unstable, heterogeneous hip fracture patient population. If the study is able to show a difference in blood loss and transfusion requirement, the long term implications of this with regards to cost and mortality can be significant.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients admitted to Bryn Mawr Hospital with fracture of the femoral neck, intertrochanteric region, or subtrochanteric region of the femur will be considered for the study.

Exclusion criteria

Exclusion criteria include

• age under 18
• allergy to TA
• known current or history of venous thromboembolism (VTE)
• history of known coagulopathy or bleeding disorder
• current subarachnoid hemorrhage
• previous history of seizures
• current use of estrogen/progesterone therapy
• renal failure defined as creatinine clearance less than 30 ml/min4
• multiple fractures
• pregnant or breastfeeding women
• planned nonoperative management of the fracture

Trial design

0 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Treatment:

Drug: Control: Saline

Interventional

Active Comparator group

Treatment:

Drug: Tranexamic Acid