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
|Condition or disease||Intervention/treatment||Phase|
|Hip Fracture Surgical Intervention||Drug: Iron sucrose||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy and Safety of Intravenous Iron Sucrose in Patients With Hip Fracture to Prevent Perioperative Anemia|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||December 2012|
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084122
|Contact: Anna Cruceta, MDfirstname.lastname@example.org|
|Contact: Anna Domingo, MDemail@example.com|
|Servicio de Cirugía Ortopédica y Traumatología. Hospital Clinic.|
|Barcelona, Spain, 08036|
|Contact: Anna Domingo, MD 932275533 firstname.lastname@example.org|