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

Hospital Clinic of Barcelona360 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

360

Conditions

Hip Fracture Surgical Intervention

Interventions

Iron sucroseDRUG

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Transfusional needs

Blood transfusion rate in patients over 65 years undergone hip fracture and surgical intervention.

Time frame: 1st, 5th day and 1st and 6 th month after surgical intervention.

Secondary Outcomes

Units of packed cells

Packed cells average.

Time frame: 1st and 5th days, 1st and 6th month after surgical intervention.

Postoperative complications

Infections, adverse reactions.

Time frame: 1st and 5th day , 1st and 6th month after surgical intervention.

Central Contacts

Anna Cruceta, MD

CONTACT

932279838 acruceta@clinic.ub.es

Anna Domingo, MD

CONTACT

932279871 adomingo@clinic.ub.es

Data from ClinicalTrials.gov

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