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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

March 9, 2010
March 9, 2010
May 2010
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia
Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Hip Fracture
  • Surgical Intervention
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
360
Not Provided
December 2012   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact: Anna Cruceta, MD 932279838 acruceta@clinic.ub.es
Contact: Anna Domingo, MD 932279871 adomingo@clinic.ub.es
Spain
 
NCT01084122
FEIV-DC-09
No
Anna Domingo Trepat, Hospital Clinic
Hospital Clinic of Barcelona
Not Provided
Not Provided
Hospital Clinic of Barcelona
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP