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

Phase 4

• Conditions: Hip Fracture; Surgical Intervention

• Registration Number: NCT01084122
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

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 Timeline

• Status Verified: 2010-01
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-09
• Last Update Submitted: 2010-03-09
• Study First Posted: 2010-03-10
• Last Update Posted: 2010-03-10
• Study Start: 2010-05
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Transfusional needs	1st, 5th day and 1st and 6 th month after surgical intervention.	Blood transfusion rate in patients over 65 years undergone hip fracture and surgical intervention.

Secondary Outcome Measures

Name	Time	Method
Units of packed cells	1st and 5th days, 1st and 6th month after surgical intervention.	Packed cells average.
Postoperative complications	1st and 5th day , 1st and 6th month after surgical intervention.	Infections, adverse reactions.

Trial Locations

Locations (1)

Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.; 🇪🇸 Barcelona, Spain