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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Hospital Clinic of Barcelona.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01084122
First received: March 9, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hip Fracture
Surgical Intervention
Drug: Iron sucrose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Transfusional needs [ Time Frame: 1st, 5th day and 1st and 6 th month after surgical intervention. ] [ Designated as safety issue: No ]
    Blood transfusion rate in patients over 65 years undergone hip fracture and surgical intervention.


Secondary Outcome Measures:
  • Units of packed cells [ Time Frame: 1st and 5th days, 1st and 6th month after surgical intervention. ] [ Designated as safety issue: No ]
    Packed cells average.

  • Postoperative complications [ Time Frame: 1st and 5th day , 1st and 6th month after surgical intervention. ] [ Designated as safety issue: No ]
    Infections, adverse reactions.


Estimated Enrollment: 360
Study Start Date: May 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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.
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084122

Contacts
Contact: Anna Cruceta, MD 932279838 acruceta@clinic.ub.es
Contact: Anna Domingo, MD 932279871 adomingo@clinic.ub.es

Locations
Spain
Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic. Not yet recruiting
Barcelona, Spain, 08036
Contact: Anna Domingo, MD    932275533    adomingo@clinic.ub.es   
Sponsors and Collaborators
Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Anna Domingo Trepat, Hospital Clinic
ClinicalTrials.gov Identifier: NCT01084122     History of Changes
Other Study ID Numbers: FEIV-DC-09
Study First Received: March 9, 2010
Last Updated: March 9, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
Intravenous iron sucrose
Anemia
Transfusion

Additional relevant MeSH terms:
Hip Injuries
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Leg Injuries
Iron
Ferric oxide, saccharated
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014