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

Hospital Clinic of Barcelona

Status and phase

Unknown

Phase 4

Conditions

Hip Fracture

Surgical Intervention

Treatments

Drug: Iron sucrose

Study type

Interventional

Funder types

Other

Identifiers

NCT01084122

FEIV-DC-09

Details and patient eligibility

About

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.

Full description

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.

Enrollment

360 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.