Tranexamic Acid in HIp Fracture Surgery (THIF Study)

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.

Detailed Description
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Studies in hip and knee arthroplasty (scheduled surgery) have shown that tranexamic acid decreases allogeneic red blood cell transfusion. In hip fracture surgery, an emergent procedure, transfusion is frequent. Transfusion increases adverse events such as postoperative bacterial infection and venous thrombosis. The purpose of this study is to assess the efficacy of tranexamic acid, an anti-fibrinolytic agent, in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. The trial will also evaluate if the reduction in transfusion will be associated with less postoperative infection and without an increase in the thrombotic risk. Patients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg IV at skin incision and three hours later or saline.Patients will receive fondaparinux for prophylaxis of venous thrombosis.

Official Title
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Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.

Conditions
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Hip Fracture

Intervention / Treatment
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* Drug: Tranexamic acid (Exacyl)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requiring surgery for an isolated hip fracture of less than 48 hours Exclusion Criteria: Contraindication to tranexamic acid Contraindication to fondaparinux Contraindication to general anesthesia associated with a femoral nerve block pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Exacyl | Drug: Tranexamic acid (Exacyl)<br>* 15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery<br>* Other names: Exacyl;|
| Placebo Comparator: 2<br>Physiologic serum | Drug: Placebo<br>* NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients receiving the transfusion of at least one unit of allogeneic red blood cell |  | between the begining of surgery (day 1) and the eighth post-operative day (day 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients receiving the transfusion of at least one unit of allogeneic red blood cell |  | between the administration of fondaparinux for venous thrombosis prophylaxis(8 hours after end of surgery on day 1) and the eighth post-operative day (day 8) | 
| post-operative major hemorrhage |  | day 8 | 
| post-operative blood loss |  | untill day 8 | 
| post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection) |  | untill six weeks | 
| thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis) |  | untill six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip fracture, transfusion, tranexamic acid, fondaparinux