Single Dose of Tranexamic Acid and Blood Loss, in Elderly Patients With Hip Fracture

National and Kapodistrian University of Athens200 enrolled

Overview

The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

200

Conditions

Blood Loss, Surgical Hip Fractures Complication, Postoperative

Interventions

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Consecutive elderly patients (age \>75 yo) undergoing hip fracture surgery for a stable or unstable intertrochanteric hip fracture with the insertion of a short intramedullary nail (IMN) as well as patients treated surgically with cemented hemiarthroplasty for acute femoral neck (subcapital) hip fracture. Exclusion Criteria: * Any contraindication for tranexamic acid * Multiple fractures * Requirement for anticoagulant therapy that could not be stopped. * Ongoing thromboembolic event * reduced kidney function * malignancy, * pathological fracture * previous operation on the affected hip * Active coronary artery disease (event in the past 12 months).

Outcomes

Primary Outcomes

number of transfusions of allogeneic RBC from surgery up to day 4

Time frame: 5 days

total blood loss from surgery to day

Time frame: 5 days

Secondary Outcomes

incidence of vascular events

Time frame: 3 months

Incidence of deaths