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

National and Kapodistrian University of Athens

Status and phase: Unknown; Phase 2

Conditions: Hip Fractures; Blood Loss, Surgical; Complication, Postoperative

Treatments: Drug: Tranexamic Acid 15mg/kg , iv, Single Dose; Drug: Normal Saline, 100mg, iv, Singe dose

Study type: Interventional

Funder types: Other

Identifiers

NCT03251469

2

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

intravenous tranexamic acid, 15mg/kg, preoperatively, single dose

Treatment:

Drug: Tranexamic Acid 15mg/kg , iv, Single Dose

Group 2

Placebo Comparator group

Description:

Intravenous normal saline, 100mg, preoperatively, single dose

Treatment:

Drug: Normal Saline, 100mg, iv, Singe dose