Back to resultsIntravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery (PRIVIRON)
Primary Purpose
Anemia, Orthopedic Surgery, High Risk of Blood Loss
Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Ferinject 50 mg/ml
NaCl 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring anemia, transfusion, intravenous ferric carboxymaltose
Eligibility Criteria
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
Sites / Locations
- Charité Universitätsmedizin Berlin
- University Hospital Muenster
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
NaCl 0.9%
Ferinject
Arm Description
Outcomes
Primary Outcome Measures
Number of RBC units
Secondary Outcome Measures
Blood transfusion rate
Number of patients with blood transfusions
Frequency of postoperative complications
Number of postoperative complications from baseline until postoperative day 7
Frequency of postoperative complications
Number of postoperative complication from baseline until 6 weeks after surgical intervention
Length of hospital stay
Full Information
NCT ID
NCT01345968
First Posted
April 21, 2011
Last Updated
August 7, 2013
Sponsor
University Hospital Muenster
Collaborators
Vifor Pharma
1. Study Identification
Unique Protocol Identification Number
NCT01345968
Brief Title
Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery
Acronym
PRIVIRON
Official Title
Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Why Stopped
Less patients than expected for inclusion, therefore recruitment is too low
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster
Collaborators
Vifor Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Orthopedic Surgery, High Risk of Blood Loss
Keywords
anemia, transfusion, intravenous ferric carboxymaltose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NaCl 0.9%
Arm Type
Placebo Comparator
Arm Title
Ferinject
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ferinject 50 mg/ml
Intervention Description
iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes
Intervention Type
Drug
Intervention Name(s)
NaCl 0.9%
Intervention Description
iv administration of max. 50 ml in 30 minutes
Primary Outcome Measure Information:
Title
Number of RBC units
Time Frame
Until postoperative day 7
Secondary Outcome Measure Information:
Title
Blood transfusion rate
Description
Number of patients with blood transfusions
Time Frame
Until postoperative day 7
Title
Frequency of postoperative complications
Description
Number of postoperative complications from baseline until postoperative day 7
Time Frame
Until postoperative day 7
Title
Frequency of postoperative complications
Description
Number of postoperative complication from baseline until 6 weeks after surgical intervention
Time Frame
Until 6 weeks after surgical intervention
Title
Length of hospital stay
Time Frame
6 weeks after surgical intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo K Van Aken, PhD, MD
Organizational Affiliation
Department of Anesthesia and Intensiv Care, University Hospital Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
University Hospital Muenster
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery
We'll reach out to this number within 24 hrs