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

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ClinicalTrials.gov Identifier: NCT01084122
Recruitment Status : Unknown
Verified January 2010 by Hospital Clinic of Barcelona.
Recruitment status was:  Not yet recruiting
First Posted : March 10, 2010
Last Update Posted : March 10, 2010
Sponsor:
Information provided by:
Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE March 9, 2010
First Posted Date  ICMJE March 10, 2010
Last Update Posted Date March 10, 2010
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
Transfusional needs [ Time Frame: 1st, 5th day and 1st and 6 th month after surgical intervention. ]
Blood transfusion rate in patients over 65 years undergone hip fracture and surgical intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2010)
  • Units of packed cells [ Time Frame: 1st and 5th days, 1st and 6th month after surgical intervention. ]
    Packed cells average.
  • Postoperative complications [ Time Frame: 1st and 5th day , 1st and 6th month after surgical intervention. ]
    Infections, adverse reactions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia
Official Title  ICMJE Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Hip Fracture
  • Surgical Intervention
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 9, 2010)
360
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01084122
Other Study ID Numbers  ICMJE FEIV-DC-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anna Domingo Trepat, Hospital Clinic
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Clinic of Barcelona
Verification Date January 2010

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