AnemiaPhase 4PRIVIRONNCT01345968
Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery
A Phase 4 study testing Ferinject 50 mg/ml and NaCl 0.9% in people with Anemia and Orthopedic Surgery, run by University Hospital Muenster at 2 sites in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Orthopedic Surgery, High Risk of Blood Loss
- What is being tested?
- Ferinject 50 mg/ml and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2011to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité Universitätsmedizin Berlin
Berlin
University Hospital Muenster
Münster, D-48149
About this study
Official title: Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss
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
- Conditions
- Anemia, Orthopedic Surgery, High Risk of Blood Loss
- Being tested
- Ferinject 50 mg/ml, NaCl 0.9%
- Keywords
- anemia, transfusion, intravenous ferric carboxymaltose
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferinject 50 mg/mlDrug
iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes
NaCl 0.9%Drug
iv administration of max. 50 ml in 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| NaCl 0.9% | Placebo comparator | Not described Receives: Drug: NaCl 0.9% |
| Ferinject | Experimental | Not described Receives: Drug: Ferinject 50 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of RBC units
Measured: Until postoperative day 7
Secondary outcomes (4)
Blood transfusion rate
Number of patients with blood transfusions
Measured: Until postoperative day 7
Frequency of postoperative complications
Number of postoperative complications from baseline until postoperative day 7
Measured: Until postoperative day 7
Frequency of postoperative complications
Number of postoperative complication from baseline until 6 weeks after surgical intervention
Measured: Until 6 weeks after surgical intervention
Length of hospital stay
Measured: 6 weeks after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionFeb 2013
Why it stopped: Less patients than expected for inclusion, therefore recruitment is too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
- Investigators
- Hugo K Van Aken, PhD, MD, Principal investigator, Department of Anesthesia and Intensiv Care, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345968
- Sponsor's protocol ID
- UKM10_0027
- Other IDs
- 2010-024115-14, 05-AnIt-09
- Acronym
- PRIVIRON
- Status last verified
- Jul 2013
- First submitted
- 21 Apr 2011
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss
- ClinicalTrials.gov ID
- NCT01345968
- Acronym / sponsor ID
- PRIVIRON / UKM10_0027
- Conditions
- Anemia, Orthopedic Surgery, High Risk of Blood Loss
- Keywords
- anemia, transfusion, intravenous ferric carboxymaltose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Less patients than expected for inclusion, therefore recruitment is too low
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NaCl 0.9% | Placebo comparator | Drug: NaCl 0.9% |
| Ferinject | Experimental | Drug: Ferinject 50 mg/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferinject 50 mg/mliv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes | Drug | Ferinject |
| NaCl 0.9%iv administration of max. 50 ml in 30 minutes | Drug | NaCl 0.9% |
Primary outcome
Number of RBC units
Time frame: Until postoperative day 7
4 secondary outcomes
Blood transfusion rate
Time frame: Until postoperative day 7
Frequency of postoperative complications
Time frame: Until postoperative day 7
Frequency of postoperative complications
Time frame: Until 6 weeks after surgical intervention
Length of hospital stay
Time frame: 6 weeks after surgical intervention
Results and safety
The study was stopped early (reason given: Less patients than expected for inclusion, therefore recruitment is too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugo K Van Aken, PhD, MD principal investigator
Department of Anesthesia and Intensiv Care, University Hospital Muenster
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferinject 50 mg/ml and NaCl 0.9% in people with Anemia and Orthopedic Surgery, run by University Hospital Muenster at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Less patients than expected for inclusion, therefore recruitment is too low). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of RBC units (time frame: Until postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.