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

Hip Fractures Clinical Trial

Official title:

Single Dose of Tranexamic Acid at the Time of Surgery and Blood Loss, in Elderly Patients Undergoing Hip Fracture Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03251469
• Other study ID #: 2
• Status: Recruiting
• Phase: Phase 2
• First received: November 29, 2016
• Last updated: August 15, 2017
• Start date: January 2013
• Est. completion date: February 2018

Study information

• Verified date: August 2017
• Source: National and Kapodistrian University of Athens
• Contact: Vasileios S Nikolaou, MD
• Phone: +306932543400
• Email: vassilios.nikolaou[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Complication, Postoperative
• Fractures, Bone
• Hemorrhage
• Hip Fractures
• Postoperative Complications

Intervention

Drug:
• Tranexamic Acid 15mg/kg , iv, Single Dose
Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose
• Normal Saline, 100mg, iv, Singe dose
Normal Saline, 100mg, administered intravenously, preoperatively in single dose

Locations

Country	Name	City	State
Greece	2nd Department of Orthopaedics	Athens	Attika

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of transfusions of allogeneic RBC from surgery up to day 4		5 days
Primary	total blood loss from surgery to day		5 days
Secondary	incidence of vascular events		3 months
Secondary	Incidence of deaths		3 months