Study Stopped
Less patients than expected for inclusion, therefore recruitment is too low
Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery
PRIVIRON
Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss
3 other identifiers
interventional
3
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
May 2, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedAugust 9, 2013
July 1, 2013
1.6 years
April 21, 2011
August 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of RBC units
Until postoperative day 7
Secondary Outcomes (4)
Blood transfusion rate
Until postoperative day 7
Frequency of postoperative complications
Until postoperative day 7
Frequency of postoperative complications
Until 6 weeks after surgical intervention
Length of hospital stay
6 weeks after surgical intervention
Study Arms (2)
NaCl 0.9%
PLACEBO COMPARATORFerinject
EXPERIMENTALInterventions
iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes
Eligibility Criteria
You may qualify if:
- age \>= 18 years
- Patients scheduled to undergo hip or knee replacement
- 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
You may not qualify if:
- 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
- liver values 3 times higher than normal
- active severe infection/inflammation
- renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Muensterlead
- Vifor Pharmacollaborator
Study Sites (2)
Charité Universitätsmedizin Berlin
Berlin, Germany
University Hospital Muenster
Münster, D-48149, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugo K Van Aken, PhD, MD
Department of Anesthesia and Intensiv Care, University Hospital Muenster
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2011
First Posted
May 2, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
August 9, 2013
Record last verified: 2013-07