Efficacy and Safety of Intravenous Iron Sucrose in Patien... | NCT01084122

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

NCT01084122

Sponsor

Hospital Clinic of Barcelona

Status

Unknown status

Last Update Posted

Mar 10, 2010Estimated

Enrollment

360Estimated

Phase

Phase 4

Conditions

Hip Fracture
Surgical Intervention

Interventions

Iron sucrose

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2012Estimated

Completion Date

Not provided

First Submitted Date

Mar 9, 2010

First Submission Date that Met QC Criteria

Mar 9, 2010

First Posted Date

Mar 10, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2010

Last Update Posted Date

Mar 10, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

360Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iron sucrose	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anna Cruceta, MD	Contact	932279838		acruceta@clinic.ub.es
Anna Domingo, MD	Contact	932279871		adomingo@clinic.ub.es

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.		Barcelona	Barcelona	08036	Spain

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures
D000740	Anemia

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077605	Ferric Oxide, Saccharated

Ancestor Terms

ID	Term
D005290	Ferric Compounds
D058085	Iron Compounds
D007287	Inorganic Chemicals
D005937	Glucaric Acid

Browse Leaves

Not provided

Browse Branches

Not provided