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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hip Fracture Surgical Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No