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

Hip Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01084122
• Other study ID #: FEIV-DC-09
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 9, 2010
• Last updated: March 9, 2010
• Start date: May 2010

Study information

• Verified date: January 2010
• Source: Hospital Clinic of Barcelona
• Contact: Anna Cruceta, MD
• Phone: 932279838
• Email: acruceta[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Surgical Intervention

Intervention

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.

Locations

Country	Name	City	State
Spain	Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Units of packed cells	Packed cells average.	1st and 5th days, 1st and 6th month after surgical intervention.	No
Secondary	Postoperative complications	Infections, adverse reactions.	1st and 5th day , 1st and 6th month after surgical intervention.	No