AnemiaNCT02385409
Incidence and Reasons for Preoperative Anemia in Elective Lower Joint Arthroplasty
An observational study of Anemia and Arthroplasty, Replacement, Hip, run by Oeivind Jans at 1 site in Denmark.
Trial summary
Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity. Treatment of preoperative anemia is recommended. However the type of preoperative anemias in elective hip- and knee surgery has only been sparsely studied. 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
- How many people
- 900 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to May 2015
- 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: All patients scheduled for elective primary hip- and knee replacement during a 1 year sampling period at the department of orthopedic surgery, Hvidovre Hospital, Denmark
Who may be able to join
- Age > 18 years
- Scheduled for elective primary hip- or knee replacement.
Who cannot join
- Not possible to obtain preoperative blood sample.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hvidovre Hospital, Department of orthopaedic surgery
Hvidovre, 2650
About this study
Official title: Incidence and Reasons for Preoperative Anemia in Elective Lower Joint Arthroplasty - A Descriptive Study
Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.
Treatment of preoperative anemia is recommended. However the type of preoperative anemias in elective hip- and knee surgery has only been sparsely studied.
This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.
Read the detailed description
Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.
In elective orthopedic surgery, international guidelines recommends treatment of preoperative anemia including the use of Iron supplements for anemias associated with iron deficiency. In addition, low iron stores in both anemic and non-anemic patients may delay postoperative hemoglobin recovery.
However, the reasons for preoperative anemia and the prevalence of patients with low iron stores have only been sparsely studied in elective hip- and knee arthroplasty.
This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.
- Keywords
- Patient Blood Management, Preoperative anemia, Hip replacement, Knee replacement
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elective Total Hip- or Knee arthroplasty patients | Patients scheduled for elective Hip- or knee replacement at Hvidovre Hospital, Denmark. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia Classification - Biochemical classification from preoperative venous blood samples
Biochemical classification from preoperative venous blood samples
Measured: Date of preoperative blood sampling
Secondary outcomes (2)
Prevalence of Anemia according to WHO definitions
According to WHO definitions
Measured: Date of preoperative blood sampling
Proportions of non-anemic patients with low irons stores
Low Ferritin or Transferin saturation (TSAT)
Measured: Date of preoperative blood sampling
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 startMay 2013
- Primary completionMay 2014
- Study completionMay 2015 (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.
- 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oeivind Jans
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Sponsor-investigator, Oeivind Jans, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Øivind Jans, M.D., Ph.D., Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385409
- Sponsor's protocol ID
- RH-4074-OJ5
- 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
- Incidence and Reasons for Preoperative Anemia in Elective Lower Joint Arthroplasty - A Descriptive Study
- ClinicalTrials.gov ID
- NCT02385409
- Acronym / sponsor ID
- RH-4074-OJ5
- Keywords
- Patient Blood Management, Preoperative anemia, Hip replacement, Knee replacement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Oeivind JansUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2015 (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.
Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.
Treatment of preoperative anemia is recommended. However the type of preoperative anemias in elective hip- and knee surgery has only been sparsely studied.
This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.
Detailed description
Preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity.
In elective orthopedic surgery, international guidelines recommends treatment of preoperative anemia including the use of Iron supplements for anemias associated with iron deficiency. In addition, low iron stores in both anemic and non-anemic patients may delay postoperative hemoglobin recovery.
However, the reasons for preoperative anemia and the prevalence of patients with low iron stores have only been sparsely studied in elective hip- and knee arthroplasty.
This observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Total Hip- or Knee arthroplasty patients | – | –Patients scheduled for elective Hip- or knee replacement at Hvidovre Hospital, Denmark. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for elective primary hip- and knee replacement during a 1 year sampling period at the department of orthopedic surgery, Hvidovre Hospital, Denmark
Key inclusion criteria (2 listed)
- Age > 18 years
- Scheduled for elective primary hip- or knee replacement.
Key exclusion criteria (1 listed)
- Not possible to obtain preoperative blood sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anemia Classification - Biochemical classification from preoperative venous blood samples
Time frame: Date of preoperative blood sampling
Biochemical classification from preoperative venous blood samples
2 secondary outcomes
Prevalence of Anemia according to WHO definitions
Time frame: Date of preoperative blood sampling
Proportions of non-anemic patients with low irons stores
Time frame: Date of preoperative blood sampling
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.
Øivind Jans, M.D., Ph.D. study director
Copenhagen University Hospital, Rigshospitalet
1 site 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 Oeivind Jans at 1 site 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 2 inclusion and 1 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 1 site 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?
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?
Anemia Classification - Biochemical classification from preoperative venous blood samples (time frame: Date of preoperative blood sampling). 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.