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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03251469

Enrollment

200

Registered

2017-08-16

Start date

2013-01-31

Completion date

2018-02-28

Last updated

2017-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Surgical, Complication, Postoperative, Hip Fractures

Keywords

tranexamic acid, blood tranfusion, hip fractures, elderly, blood loss

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).

Interventions

DRUGTranexamic Acid 15mg/kg , iv, Single Dose

Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose

DRUGNormal Saline, 100mg, iv, Singe dose

Normal Saline, 100mg, administered intravenously, preoperatively in single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

75 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
incidence of vascular events	3 months
Incidence of deaths	3 months

Countries

Greece

Contacts

Primary ContactVasileios S Nikolaou, MD

vassilios.nikolaou@gmail.com+306932543400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026