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

Study Overview
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Brief Summary
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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).

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

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

Intervention / Treatment
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* Drug: Tranexamic Acid 15mg/kg , iv, Single Dose
* Drug: Normal Saline, 100mg, iv, Singe dose


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>intravenous tranexamic acid, 15mg/kg, preoperatively, single dose | Drug: Tranexamic Acid 15mg/kg , iv, Single Dose<br>* Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose<br>|
| Placebo Comparator: Group 2<br>Intravenous normal saline, 100mg, preoperatively, single dose | Drug: Normal Saline, 100mg, iv, Singe dose<br>* Normal Saline, 100mg, administered intravenously, preoperatively in single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of vascular events |  | 3 months | 
| Incidence of deaths |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tranexamic acid, blood tranfusion, hip fractures, elderly, blood loss