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

Phase 2

• Conditions: Blood Loss, Surgical; Hip Fractures; Complication, Postoperative
• Interventions: Drug: Tranexamic Acid 15mg/kg , iv, Single Dose; Drug: Normal Saline, 100mg, iv, Singe dose

• Registration Number: NCT03251469
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-11-29
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-15
• Last Update Submitted: 2017-08-15
• Study First Posted: 2017-08-16
• Last Update Posted: 2017-08-16
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Tranexamic Acid 15mg/kg , iv, Single Dose	intravenous tranexamic acid, 15mg/kg, preoperatively, single dose
Group 2	Normal Saline, 100mg, iv, Singe dose	Intravenous normal saline, 100mg, preoperatively, single dose

Primary Outcome Measures

Name	Time	Method
total blood loss from surgery to day	5 days
number of transfusions of allogeneic RBC from surgery up to day 4	5 days

Secondary Outcome Measures

Name	Time	Method
incidence of vascular events	3 months
Incidence of deaths	3 months

Trial Locations

Locations (1)

2nd Department of Orthopaedics; 🇬🇷 Athens, Attika, Greece