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

Primary Purpose

Hip Fracture, Surgical Intervention

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Iron sucrose

About this trial

This is an interventional prevention trial for Hip Fracture focused on measuring Intravenous iron sucrose, Anemia, Transfusion

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.

Outcomes

Primary Outcome Measures

Transfusional needs

Blood transfusion rate in patients over 65 years undergone hip fracture and surgical intervention.

Secondary Outcome Measures

Units of packed cells

Packed cells average.

Postoperative complications

Infections, adverse reactions.

Full Information

NCT ID

NCT01084122

First Posted

March 9, 2010

Last Updated

March 9, 2010

Sponsor

Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT01084122

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

May 2010 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Fracture, Surgical Intervention

Keywords

Intravenous iron sucrose, Anemia, Transfusion

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

360 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Iron sucrose

Intervention Description

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.

Primary Outcome Measure Information:

Title

Transfusional needs

Description

Blood transfusion rate in patients over 65 years undergone hip fracture and surgical intervention.

Time Frame

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

Secondary Outcome Measure Information:

Title

Units of packed cells

Description

Packed cells average.

Time Frame

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

Title

Postoperative complications

Description

Infections, adverse reactions.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Cruceta, MD

Phone

932279838

acruceta@clinic.ub.es

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Domingo, MD

Phone

932279871

adomingo@clinic.ub.es

Facility Information:

Facility Name

Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Domingo, MD

Phone

932275533

adomingo@clinic.ub.es

12. IPD Sharing Statement

Learn more about this trial

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

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