AnemiaNCT00967109
Establishment of Optimal Transfusion Threshold During Spine Surgery
A study testing Allowed drop in hemoglobin to level between 4,5-5,6 mmol/L and Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L in people with Anemia and Spine Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Spine Surgery
- What is being tested?
- Allowed drop in hemoglobin to level between 4,5-5,6 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
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Feb 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 spine surgery
- Be legally competent
- Read and understand Danish
Who cannot join
- Present malignant disease
- Previously apoplexia cerebri
- Known heart disease with functionality equivalent to NYHA II or CCS II or worse
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether a higher threshold for transfusion with red blood cells improves the tissue oxygenation.
- Conditions
- Anemia, Spine Surgery
- Being tested
- Allowed drop in hemoglobin to level between 4,5-5,6 mmol/L, Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L
- Keywords
- Anemia, Tissue oxygenation, Spine surgery
- 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 level between 4,5-5,6 mmol/LOther
Transfusion with red blood cells to hemoglobin level between 4,5-5,5 mmol/L
Allowed drop in hemoglobin to level between 5,6-6,5 mmol/LOther
Transfusion with red blood cells to hemoglobin level between 5,6-6,5 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 level between 4,5-5,6 mmol/L |
| Allowed drop in hemoglobin to 5,5-6,5 mmol/L | Experimental | Transfusion with red blood cells to level between 5.5-6.5 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.
The change in subcutaneous oxygen tension from incision.
The primary endpoint is the change in subcutaneous oxygen tension from incision until the time most patients is still undergoing surgery. Subcutaneous oxygen tension is measured every fifteen minutes throughout surgery. The oxygen tension is measured with a polygraphic electrode (Clark's electrode).
Measured: Every fifteen minutes throughout surgery
Secondary outcomes (5)
Oxygenation of the brain
Measured: Every fifteen minutes throughout surgery
The concentration of lactate in plasma
Measured: Every half an hour throughout surgery
Variation in the ST-segment of the ECG
Measured: Every fifteen minutes throughout surgery
Muscular saturation of the deltoid muscle
The change in muscular saturation from incision until the time when most patientes are still undergoing surgery. Furthermore the lowest measured and the last measured muscular saturation is also evaluated.
Measured: Every fifteen minutes throughout surgery
The change in subcutaneous oxygen tension from incision.
The lowest measured subcutaneous oxygen tension and the last measured subcutaneous oxygen tension throughout surgery.
Measured: Every fifteen minutes throughout surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionFeb 2011
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- NCT00967109
- Sponsor's protocol ID
- H-C-2009-072
- Status last verified
- Feb 2011
- First submitted
- 24 Aug 2009
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Optimal Transfusion Threshold During Spine Surgery
- ClinicalTrials.gov ID
- NCT00967109
- Acronym / sponsor ID
- H-C-2009-072
- Conditions
- Anemia, Spine Surgery
- Keywords
- Anemia, Tissue oxygenation, Spine surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Aug 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 tissue oxygenation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, 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 level between 4,5-5,6 mmol/LTransfusion with red blood cells to level between 4.5-5.5 mmol/L |
| Allowed drop in hemoglobin to 5,5-6,5 mmol/L | Experimental | Other: Allowed drop in hemoglobin to level between 5,6-6,5 mmol/LTransfusion with red blood cells to level between 5.5-6.5 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 spine surgery
- Be legally competent
- Read and understand Danish
Key exclusion criteria (3 listed)
- Present malignant disease
- Previously apoplexia cerebri
- 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 level between 4,5-5,6 mmol/LTransfusion with red blood cells to hemoglobin level between 4,5-5,5 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 hemoglobin level between 5,6-6,5 mmol/L | Other | Allowed drop in hemoglobin to 5,5-6,5 mmol/L |
Primary outcome
The change in subcutaneous oxygen tension from incision.
Time frame: Every fifteen minutes throughout surgery
The primary endpoint is the change in subcutaneous oxygen tension from incision until the time most patients is still undergoing surgery. Subcutaneous oxygen tension is measured every fifteen minutes throughout surgery. The oxygen tension is measured with a polygraphic electrode (Clark's electrode).
5 secondary outcomes
Oxygenation of the brain
Time frame: Every fifteen minutes throughout surgery
The concentration of lactate in plasma
Time frame: Every half an hour throughout surgery
Variation in the ST-segment of the ECG
Time frame: Every fifteen minutes throughout surgery
Muscular saturation of the deltoid muscle
Time frame: Every fifteen minutes throughout surgery
The change in subcutaneous oxygen tension from incision.
Time frame: Every fifteen minutes throughout surgery
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 25 Feb 2011.
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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
1 site 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 level between 4,5-5,6 mmol/L and Allowed drop in hemoglobin to level between 5,6-6,5 mmol/L in people with Anemia and Spine Surgery, run by Copenhagen University Hospital, Rigshospitalet 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 4 inclusion and 3 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 25 Feb 2011. 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?
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?
The change in subcutaneous oxygen tension from incision. (time frame: Every fifteen minutes throughout surgery). 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 25 Feb 2011.