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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01084122

Enrollment

360

Registered

2010-03-10

Start date

2010-05-31

Completion date

Unknown

Last updated

2010-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture, Surgical Intervention

Keywords

Intravenous iron sucrose, Anemia, Transfusion

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.

Interventions

DRUGIron 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Contacts

Primary ContactAnna Cruceta, MD

acruceta@clinic.ub.es932279838

Backup ContactAnna Domingo, MD

adomingo@clinic.ub.es932279871

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026