AnemiaNCT02385383
An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study
An observational study of Anemia and Arthroplasty, Replacement, Hip, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
Trial summary
This observational study follows a cohort of patients scheduled for elective hip- or knee surgery but has preoperative anemia and are treated with Intravenous (IV) iron prior to surgery according to a recently introduced standardized treatment protocol at 6 high-volume surgical centres. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- What is being tested?
- Iron-III Isomaltoside 1000
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 6 sitesDenmark
- Study dates
- Oct 2014to Feb 2017
- Phase
- Observational
- 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
Study population: Patients scheduled for elective hip or knee arthroplasty presenting with preoperative anemia.
Who may be able to join
- Age > 18 years
- Scheduled for elective primary hip- or knee arthroplasty
- Preoperative hemoglobin < 13 g/dl (males) or < 12 g/dl (females)
- Included in the departments treatment protocol for preoperative anemia
Who cannot join
- Cronic transfusion need
- Not able to give consent
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Denmark6 sites, 6 recruiting
- Recruiting
Bisbebjerg Hospital, Dept. of orthopedic surgery
Copenhagen NV, 2400
Jens Bagger, M.D.
- Recruiting
Farsø Sygehus
Farsø, 9640
- Recruiting
Gentofte Hospital, Dept. of orthopedic surgery
Hellerup, 2900
Søren Solgaard, M.D.
Søren Solgaard
- Recruiting
Hvidovre Hospital, Department of orthopaedic surgery
Hvidovre, 2650
Henrik Husted, henrik.husted@hvh.regionh.dk
Henrik Husted
- Recruiting
Vejle Sygehus, Dept. of orthopedic surgery
Vejle, 7100
Per Kjærsgaard-Andersen, M.D.
Per Kjærsgaard-Andersen, M.D.
- Recruiting
Viborg Sygehus, Dept. of orthopedic surgery
Viborg, 8800
About this study
Official title: An Intravenous Iron Based Protocol for Optimizing Haemoglobin in Anaemic Patients Prior to Fast-track Hip and Knee Arthroplasty - An Observational Follow up Study
This observational study follows a cohort of patients scheduled for elective hip- or knee surgery but has preoperative anemia and are treated with Intravenous (IV) iron prior to surgery according to a recently introduced standardized treatment protocol at 6 high-volume surgical centres.
Read the detailed description
Patients presenting with preoperative anaemia prior to hip and knee arthroplasty has a high risk of receiving allogeneic blood transfusion and anaemia has been associated with increased postoperative morbidity and mortality. While IV-iron administration may raise Hb prior to surgery, existing guidelines for addressing and treating preoperative anaemia is not widely implemented for patients scheduled for elective total joint arthroplasty (TJA) in Denmark. In addition, causes of preoperative anaemia and the efficacy of preoperative IV-iron administration has not been sufficiently evaluated in elective TJA.
This is a observational follow-up study among 6 Danish high volume surgical centres that has recently introduced a standardized anaemia screening and treatment protocol for patients with preoperative anaemia scheduled for total hip- or knee arthroplasty.
Patients with iron deficiency anaemia or anaemia of chronic inflammation receive infusion of IV-iron (Monofer) 4 weeks prior to surgery as a part of the standard operating procedure on the department.
The aim of this follow up study is to evaluate changes in Haemoglobin concentration, transfusion rate and postoperative morbidity in this cohort.
- Being tested
- Iron-III Isomaltoside 1000, Standard Care
- Keywords
- Patient Blood Management, Preoperative anemia, IV Iron
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron-III Isomaltoside 1000Drug
Also called Monofer
Protocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000
Standard CareOther
Standard Care in a historical control cohort
| Study group | Role | What they receive |
|---|---|---|
| Patients with preoperative anemia following treatment protocol | Patients with preoperative anemia according to the WHO definition and treated with a protocol of Iitravenous iron prior to surgery Receives: Drug: Iron-III Isomaltoside 1000 | |
| Patients with preoperative anemia - Historical control | Cohort of preoperative anemic patients from the Lundbeckcentre Database. Serving as a historical control Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion Rate
Blood transfusion (yes/no) during the entire hospital stay
Measured: From date of admission to date of discharge (up to 30 days)
Secondary outcomes (5)
Classification of preoperative anemia
Measured: 4 weeks prior to surgery (baseline)
Change in hemoglobin concentration
The change in Hb from the time of preoperative blood sampling to Hb sampled on the date of admission
Measured: From date of preoperative blood sampling (baseline) to date of admission (Up to 4 weeks)
No. of red blood cell units administered per patient
No of blood units administered during the entire hospital stay
Measured: From date of admission to date of discharge (up to 30 days)
Length of Hospital stay
Measured: From date of admission to Date of discharge (up to 30 days)
Postoperative complications and readmissions
Measured: From date of surgery up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionFeb 2017 (estimated)
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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Bispebjerg Hospital, Gentofte Hospital, Vejle Sygehus, Regionshospitalet Viborg, Skive, Farsø Sygehus
- Responsible party
- Principal investigator, Oeivind Jans, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Oeivind Jans, M.D., Ph.D., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385383
- Sponsor's protocol ID
- RH-4074-OJ4
- Status last verified
- Mar 2015
- First submitted
- 16 Feb 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intravenous Iron Based Protocol for Optimizing Haemoglobin in Anaemic Patients Prior to Fast-track Hip and Knee Arthroplasty - An Observational Follow up Study
- ClinicalTrials.gov ID
- NCT02385383
- Acronym / sponsor ID
- RH-4074-OJ4
- Keywords
- Patient Blood Management, Preoperative anemia, IV Iron
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Bispebjerg Hospital, Gentofte Hospital, Vejle Sygehus, Regionshospitalet Viborg, Skive, Farsø Sygehus
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 11 Mar 2015 (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.
This observational study follows a cohort of patients scheduled for elective hip- or knee surgery but has preoperative anemia and are treated with Intravenous (IV) iron prior to surgery according to a recently introduced standardized treatment protocol at 6 high-volume surgical centres.
Detailed description
Patients presenting with preoperative anaemia prior to hip and knee arthroplasty has a high risk of receiving allogeneic blood transfusion and anaemia has been associated with increased postoperative morbidity and mortality. While IV-iron administration may raise Hb prior to surgery, existing guidelines for addressing and treating preoperative anaemia is not widely implemented for patients scheduled for elective total joint arthroplasty (TJA) in Denmark. In addition, causes of preoperative anaemia and the efficacy of preoperative IV-iron administration has not been sufficiently evaluated in elective TJA.
This is a observational follow-up study among 6 Danish high volume surgical centres that has recently introduced a standardized anaemia screening and treatment protocol for patients with preoperative anaemia scheduled for total hip- or knee arthroplasty.
Patients with iron deficiency anaemia or anaemia of chronic inflammation receive infusion of IV-iron (Monofer) 4 weeks prior to surgery as a part of the standard operating procedure on the department.
The aim of this follow up study is to evaluate changes in Haemoglobin concentration, transfusion rate and postoperative morbidity in this cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with preoperative anemia following treatment protocol | – | Drug: Iron-III Isomaltoside 1000Patients with preoperative anemia according to the WHO definition and treated with a protocol of Iitravenous iron prior to surgery |
| Patients with preoperative anemia - Historical control | – | Other: Standard CareCohort of preoperative anemic patients from the Lundbeckcentre Database. Serving as a historical control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective hip or knee arthroplasty presenting with preoperative anemia.
Key inclusion criteria (4 listed)
- Age > 18 years
- Scheduled for elective primary hip- or knee arthroplasty
- Preoperative hemoglobin < 13 g/dl (males) or < 12 g/dl (females)
- Included in the departments treatment protocol for preoperative anemia
Key exclusion criteria (2 listed)
- Cronic transfusion need
- Not able to give consent
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 |
|---|---|---|
| Iron-III Isomaltoside 1000Also: MonoferProtocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000 | Drug | Patients with preoperative anemia following treatment protocol |
| Standard CareStandard Care in a historical control cohort | Other | Patients with preoperative anemia - Historical control |
Primary outcome
Transfusion Rate
Time frame: From date of admission to date of discharge (up to 30 days)
Blood transfusion (yes/no) during the entire hospital stay
5 secondary outcomes
Classification of preoperative anemia
Time frame: 4 weeks prior to surgery (baseline)
Change in hemoglobin concentration
Time frame: From date of preoperative blood sampling (baseline) to date of admission (Up to 4 weeks)
No. of red blood cell units administered per patient
Time frame: From date of admission to date of discharge (up to 30 days)
Length of Hospital stay
Time frame: From date of admission to Date of discharge (up to 30 days)
Postoperative complications and readmissions
Time frame: From date of surgery up to 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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.
Oeivind Jans, M.D., Ph.D. principal investigator
Copenhagen University Hospital, Rigshospitalet
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Arthroplasty, Replacement, Hip, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oeivind Jans, M.D., Ph.D. (+4521688012, oeivind.jans@rh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfusion Rate (time frame: From date of admission to date of discharge (up to 30 days)). 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 11 Mar 2015.