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

March 9, 2010 updated by: Hospital Clinic of Barcelona
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfusional needs
Time Frame: 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.
1st, 5th day and 1st and 6 th month after surgical intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Units of packed cells
Time Frame: 1st and 5th days, 1st and 6th month after surgical intervention.
Packed cells average.
1st and 5th days, 1st and 6th month after surgical intervention.
Postoperative complications
Time Frame: 1st and 5th day , 1st and 6th month after surgical intervention.
Infections, adverse reactions.
1st and 5th day , 1st and 6th month after surgical intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Estimate)

March 10, 2010

Last Update Submitted That Met QC Criteria

March 9, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEIV-DC-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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