IV Iron in Association With Tranexamic Acid for Hip Fracture

Study Overview
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Brief Summary
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It is a prospective randomized controlled study aiming to test if tranexamic acid combined to intravenous iron before and after surgery for hip fracture in elderly can decrease peri-operative red cell transfusion.

Detailed Description
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Hip fracture is an increasing problem. Anemia is a common finding in these patients with a prevalence ranging from 24% to 44% and is a strong negative prognostic marker. Several studies have explored whether interventions to improve anemia result in better outcomes. Thus, alternatives to allogenic red cell transfusion have been suggested in hip fracture, such as IV iron and tranexamic acid. The aim of the study is to test the effect of combination of IV iron with tranexamic acid before and after surgery for hip fracture on incidence of peri-operative red cell transfusion. It is a prospective randomized single-blinded monocentric study including 150 patients undergoing hip fracture surgery within 72 h after trauma aged ≥ 60 years divided in 3 groups: Group A (IV fer+Tranexamic acid), Group B (Tranexamic acid), Group C (placebo). The main outcome was percentage of patients who receive red-cell transfusion during hospitalization. Hemoglobin levels up to 60 days post-operatively and incidence of thrombotic events were secondary outcomes.

Official Title
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Use of Combined Tranexamic Acid and Intravenous Iron for Hip Fracture Surgery in Elderly

Conditions
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Hip Fracture, Anemia

Intervention / Treatment
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* Drug: tranexamic acid (Exacyl®)
* Drug: intravenous iron (Ferroven®)
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing hip fracture surgery within 72 h after trauma. Exclusion Criteria: Vascular events within the last 2 months such as cerebrovascular accident (CVA), Myocardial infarction (MI), Venous Thromboembolism (VTE) and/or recurrent VTE or arterial thrombosis. Patients receiving anticoagulation therapy with warfarin or clopidogrel. History of seizures. Multiple fractures. Transfusion received during admission, prior to surgery (Hb< 8g/dl). Creatinine clearance less than 30 mL/min Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant Coronary stent placement within the previous 6 months Disseminated intravascular coagulation Subarachnoid hemorrhage Allergy for tranexamic acid Hypersensitivity to Iron sucrose or any component of the formulation Clinical signs of acute thromboembolic event Malignancy Body weight > 100kg Advanced Dementia

Ages Eligible for Study
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Minimum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid - intravenous iron<br>IV iron (Ferroven®) : 2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three. IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later. | Drug: tranexamic acid (Exacyl®)<br>* 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later<br>Drug: intravenous iron (Ferroven®)<br>* 2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three.<br>|
| Active Comparator: Tranexamic acid<br>IV Tranexamic acid (Exacyl®): 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later. | Drug: tranexamic acid (Exacyl®)<br>* 1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later<br>|
| Placebo Comparator: Placebo<br>20 mL saline, in 30 minutes, five minutes before skin incision and 20 ml 3 hours later. | Other: Saline<br>* 20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfusion | percentage of patients who receive red-cell transfusion during hospitalization | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average red-cell packs per patient |  | 5 days | 
| blood loss | Calculated blood loss per patient from admission to day 5 postoperatively | 5 days | 
| haemoglobin level | haemoglobin level at day 1 postoperatively | day 1 | 
| haemoglobin level |  | day 2 | 
| haemoglobin level |  | day 5 | 
| haemoglobin level |  | day 30 | 
| haemoglobin level |  | day 60 | 
| Thromboembolic events | stroke or transient ischemic attack, venous thromboembolism and clinically recognized myocardial during hospital stay and until 60 days postoperatively. | day 60 | 
| Post-operative bacterial infection | urinary tract infection, lower respiratory tract infection, pneumonia and superficial or deep wound infection. | day 60 | 
| number of days in hospital | expected period of approximately 5 days | day 10 | 
| Functional mobility | ability to walk more than 10 m or outside home 60 days after hospital discharge. | day 60 | 
| mortality | in-hospital mortality | 5 days | 
| mortality |  | day 30 | 
| mortality |  | day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip fracture, anemia, blood transfusion, tranexamic acid, intravenous iron