Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia.

Detailed Description
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The main objective of this study is to evaluate the safety and efficacy of intravenous iron sucrose in patients with hip fracture and surgical intervention to prevent perioperative anemia. It will also determine whether intravenous iron sucrose administration improve outcomes as Haemoglobin values, transfusional needs, postoperative complications, length of hospital stay and cost-effectiveness.

Official Title
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Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia

Conditions
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Hip Fracture, Surgical Intervention

Intervention / Treatment
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* Drug: Iron sucrose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 65 years old With Hip fracture or peritrochanteric fracture. Who needs surgical intervention. And sign the informed consent form. Exclusion Criteria: Tumor pathological fracture. Two or more long bone fractures. Seric Ferritin levels > 300 ng/ml. Hypersensitivity to Iron sucrose or any component of the formulation. Patients with allogeneic transfusion rejection. Patients with previous blood transfusion request (Hb< 8g/dl). Patients treated with hematopoietic growth factors. Patients with Anticoagulant treatment, due to thromboembolic high risk disease. Asthma in treatment. Cirrhosis, Acute Hepatitis, or increased Aminotransferases (> 3 times the upper limit of normal). Advanced Dementia (GDS>5) from the Global Deterioration Scale.

Ages Eligible for Study
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Minimum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: Iron sucrose|Iron sucrose FERIV® (20 mg/ml). Dilution: 10 ml in 100 ml SF 0.9%. 25 ml in 15 minutes and the rest in others 15 minutes.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusional needs | Blood transfusion rate in patients over 65 years undergone hip fracture and surgical intervention. | 1st, 5th day and 1st and 6 th month after surgical intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Units of packed cells | Packed cells average. | 1st and 5th days, 1st and 6th month after surgical intervention. | 
| Postoperative complications | Infections, adverse reactions. | 1st and 5th day , 1st and 6th month after surgical intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous iron sucrose, Anemia, Transfusion