NCT01084122

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

March 10, 2010

Status Verified

January 1, 2010

Enrollment Period

2.6 years

First QC Date

March 9, 2010

Last Update Submit

March 9, 2010

Conditions

Hip FractureSurgical Intervention

Keywords

Intravenous iron sucroseAnemiaTransfusion

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (2)

  • Units of packed cells

    1st and 5th days, 1st and 6th month after surgical intervention.

  • Postoperative complications

    1st and 5th day , 1st and 6th month after surgical intervention.

Interventions

Iron sucroseDRUG

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \>= 65 years old
  • With Hip fracture or peritrochanteric fracture.
  • Who needs surgical intervention.
  • And sign the informed consent form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Hip FracturesAnemia

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Central Study Contacts

Anna Cruceta, MD

CONTACT

932279838acruceta@clinic.ub.es

Anna Domingo, MD

CONTACT

932279871adomingo@clinic.ub.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 10, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2012

Last Updated

March 10, 2010

Record last verified: 2010-01

Locations

ES(1)