Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia
Recruitment status was: Not yet recruiting
|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|
- 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.
- 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.
|Study Start Date:||May 2010|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Drug: Iron sucrose
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084122
|Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.|
|Barcelona, Spain, 08036|