AnemiaNCT00906295
Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
A study testing Allowed drop in hemoglobin to 4.5-5.5 mmol/L and Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L in people with Anemia and Arthroplasty, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Arthroplasty, Replacement
- What is being tested?
- Allowed drop in hemoglobin to 4.5-5.5 mmol/L and Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2009to Jun 2011
- Phase
- Interventional
- 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
- 18 years or older
- Patients undergoing replacement of hip arthroplasty
- Be legally competent
- Read and understand Danish
Who cannot join
- Present malignant disease
- Known heart disease with functionality equivalent to NYHA II or CCS II or worse
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Bispebjerg Hospital
Copenhagen, Copenhagen NV, 2400
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Østerbro, 2100
About this study
The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.
- Conditions
- Anemia, Arthroplasty, Replacement, Hip
- Being tested
- Allowed drop in hemoglobin to 4.5-5.5 mmol/L, Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L
- Keywords
- Hemoglobin, Ambulation
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allowed drop in hemoglobin to 4.5-5.5 mmol/LOther
Transfusion with red blood cells to hemoglobin between 4.5-5.5 mmol/L (Transfusion threshold of 4.5 mmol/L)
Allowed drop in hemoglobin to level between 5.6-6.5 mmol/LOther
Transfusion with red blood cells to between hemoglobin 5.6-6.5 mmol/L (Transfusion threshold of 5.5 mmol/L)
| Study group | Role | What they receive |
|---|---|---|
| Allowed drop in hemoglobin to 4.5-5.5 mmol/L | Active comparator | Transfusion with red blood cells to level between 4.5-5.5 mmol/L Receives: Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/L |
| Allowed drop in hemoglobin to 5.6-6.5 mmol/L | Experimental | Transfusion with red blood cells to level between 5.6-6.5 mmol/L Receives: Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go-test (TUG)in seconds.
Timed Up and Go-test is performed when the patient is able to undertake the test after surgery. This is judged by a physiotherapist. The test measures how long it takes the patient to rise, walk 3 meters, turn around, walk back and sit down again.
Measured: 30 days
Secondary outcomes (3)
The postoperative day patients can walk ten meters
Measured: 30 days
Length of stay at hospital
Measured: 30 days
The day the patient is able to perform Timed Up and Go-test
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Investigators
- Kamilla Nielsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906295
- Sponsor's protocol ID
- H-D-2009-024
- Status last verified
- Jun 2011
- First submitted
- 20 May 2009
- Last updated
- 6 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
PubMed 34932836Nielsen K, Johansson PI, Dahl B, Wagner M, Frausing B, Borglum J, Jensen K, Sturup J, Hvolris J, Rasmussen LS. Perioperative transfusion threshold and ambulation after hip revision surgery--a randomized trial. BMC Anesthesiol. 2014 Oct 10;14:89. doi: 10.1186/1471-2253-14-89. eCollection 2014.
PubMed 25337035
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT00906295
- Acronym / sponsor ID
- H-D-2009-024
- Conditions
- Anemia, Arthroplasty, Replacement, Hip
- Keywords
- Hemoglobin, Ambulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 May 2009 (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 purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allowed drop in hemoglobin to 4.5-5.5 mmol/L | Active comparator | Other: Allowed drop in hemoglobin to 4.5-5.5 mmol/LTransfusion with red blood cells to level between 4.5-5.5 mmol/L |
| Allowed drop in hemoglobin to 5.6-6.5 mmol/L | Experimental | Other: Allowed drop in hemoglobin to level between 5.6-6.5 mmol/LTransfusion with red blood cells to level between 5.6-6.5 mmol/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Patients undergoing replacement of hip arthroplasty
- Be legally competent
- Read and understand Danish
Key exclusion criteria (2 listed)
- Present malignant disease
- Known heart disease with functionality equivalent to NYHA II or CCS II or worse
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 |
|---|---|---|
| Allowed drop in hemoglobin to 4.5-5.5 mmol/LTransfusion with red blood cells to hemoglobin between 4.5-5.5 mmol/L (Transfusion threshold of 4.5 mmol/L) | Other | Allowed drop in hemoglobin to 4.5-5.5 mmol/L |
| Allowed drop in hemoglobin to level between 5.6-6.5 mmol/LTransfusion with red blood cells to between hemoglobin 5.6-6.5 mmol/L (Transfusion threshold of 5.5 mmol/L) | Other | Allowed drop in hemoglobin to 5.6-6.5 mmol/L |
Primary outcome
Timed Up and Go-test (TUG)in seconds.
Time frame: 30 days
Timed Up and Go-test is performed when the patient is able to undertake the test after surgery. This is judged by a physiotherapist. The test measures how long it takes the patient to rise, walk 3 meters, turn around, walk back and sit down again.
3 secondary outcomes
The postoperative day patients can walk ten meters
Time frame: 30 days
Length of stay at hospital
Time frame: 30 days
The day the patient is able to perform Timed Up and Go-test
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2011.
- Derived from this study: PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
- Derived from this study: PubMed 34932836Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
- Derived from this study: PubMed 25337035Nielsen K, Johansson PI, Dahl B, Wagner M, Frausing B, Borglum J, Jensen K, Sturup J, Hvolris J, Rasmussen LS. Perioperative transfusion threshold and ambulation after hip revision surgery--a randomized trial. BMC Anesthesiol. 2014 Oct 10;14:89. doi: 10.1186/1471-2253-14-89. eCollection 2014.
- Official hospital homepageLink provided by the sponsor.
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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.
Kamilla Nielsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allowed drop in hemoglobin to 4.5-5.5 mmol/L and Allowed drop in hemoglobin to level between 5.6-6.5 mmol/L in people with Anemia and Arthroplasty, run by Copenhagen University Hospital, Rigshospitalet at 2 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: finished, as of the sponsor's last update on 6 Jun 2011. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Timed Up and Go-test (TUG)in seconds. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00906295, which also lists 3 linked publications.
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 6 Jun 2011.