Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery

Anemia Clinical Trial

— PRIVIRON  

Official title:

Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01345968
• Other study ID #: UKM10_0027
• Secondary ID: 2010-024115-1405
• Status: Terminated
• Phase: Phase 4
• First received: April 21, 2011
• Last updated: August 7, 2013
• Start date: June 2011
• Est. completion date: February 2013

Study information

• Verified date: July 2013
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate the safety and efficacy of preoperative intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age >= 18 years

• Patients scheduled to undergo hip or knee replacement

• 8 g/dl < Hb < 13 g/dl for men and 8 g/dl < Hb < 12 g/dl for women at screening (3-4 weeks prior to surgery)

• anemia

• signed written informed consent

Exclusion Criteria:

• immunosuppressive or myelosuppressive therapy

• history of thromboembolic events

• a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient

• hypersensitivity to any component of the formulation

• transfusion within 1 month prior to study inclusion

• liver values 3 times higher than normal

• active severe infection/inflammation

• renal insufficiency

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Hemorrhage
• High Risk of Blood Loss
• Orthopedic Surgery

Intervention

Drug:
• Ferinject 50 mg/ml
iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes
• NaCl 0.9%
iv administration of max. 50 ml in 30 minutes

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	University Hospital Muenster	Muenster

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Muenster	Vifor Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of RBC units		Until postoperative day 7	No
Secondary	Blood transfusion rate	Number of patients with blood transfusions	Until postoperative day 7	No
Secondary	Frequency of postoperative complications	Number of postoperative complications from baseline until postoperative day 7	Until postoperative day 7	No
Secondary	Frequency of postoperative complications	Number of postoperative complication from baseline until 6 weeks after surgical intervention	Until 6 weeks after surgical intervention	No
Secondary	Length of hospital stay		6 weeks after surgical intervention	No