AnemiaNCT01328262
A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching
A study testing Calculated red blood cell transfusion and Standard red blood cell transfusion in people with Anemia, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The aim of this study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Calculated red blood cell transfusion and Standard red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receiving red cell transfusions or expected to receive one or more red cell transfusions
- Patients over 16 years of age
- Patients for whom height and weight information is available
- Patients who have consented to participate
Who cannot join
- Patients who are hemodynamically unstable (ongoing bleeding or hemolysis)
- Patients with a known hemolytic anemia (congenital or acquired)
- Patients with a positive Direct Antiglobulin Test (DAT)
- Patients for whom informed consent has not been obtained
- Patients where the hemoglobin concentration increment target is above 2g/dl.
- Patients with auto- or alloantibodies against RBCs (red blood cells)..
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the control group, the prescribed number of red cell units will be transfused.
Hypothesis: By matching the hemoglobin dose to the individual needs of the patient the investigators will reduce the total usage of red cell concentrates.
Read the detailed description
This is a randomized clinical study on hemoglobin dose and patient matching. The aim of the study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the control group, the prescribed number of red cell units will be transfused.
- Conditions
- Anemia
- Being tested
- Calculated red blood cell transfusion, Standard red blood cell transfusion
- Keywords
- Hemoglobins
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculated red blood cell transfusionOther
The subjects receive an amount of red blood cells that has been calculated from their body surface area.
Standard red blood cell transfusionOther
The subjects in this group receive the prescribed number of red blood cell units.
| Study group | Role | What they receive |
|---|---|---|
| Hemoglobin dose | Experimental | Intervention: Calculated red blood cell transfusion Receives: Other: Calculated red blood cell transfusion |
| Standard treatment | Active comparator | Intervention: Standard red blood cell transfusion Receives: Other: Standard red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Concentration Change
The change in hemoglobin concentration after transfusion was recorded. The change is defined as hemoglobin (g/dl) after transfusion minus hemoglobin (g/dl) before transfusion.
Measured: Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: Few patients, difficult to find suiting blood bags with the "right" weight.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tor A Hervig, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328262
- Sponsor's protocol ID
- 2010/476
- Status last verified
- Feb 2019
- First submitted
- 24 Feb 2011
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: If other scientists want to conduct a similar study, we will provide information that are completely anonymized. We are not in contact with any other research group now.
Publications
Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
PubMed 38780066
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on Hemoglobin Dose and Patient Matching
- ClinicalTrials.gov ID
- NCT01328262
- Acronym / sponsor ID
- 2010/476
- Conditions
- Anemia
- Keywords
- Hemoglobins
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Few patients, difficult to find suiting blood bags with the "right" weight.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Posted 17 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the control group, the prescribed number of red cell units will be transfused.
Hypothesis: By matching the hemoglobin dose to the individual needs of the patient the investigators will reduce the total usage of red cell concentrates.
Detailed description
This is a randomized clinical study on hemoglobin dose and patient matching. The aim of the study is to evaluate whether the targeted hemoglobin increment (2 grams per decilitre) in the patient can be predicted from the hemoglobin dose/weight of the blood bag transfused. In the test group, the hemoglobin dose needed will be calculated, whereas in the control group, the prescribed number of red cell units will be transfused.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemoglobin dose | Experimental | Other: Calculated red blood cell transfusionIntervention: Calculated red blood cell transfusion |
| Standard treatment | Active comparator | Other: Standard red blood cell transfusionIntervention: Standard red blood cell transfusion |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients receiving red cell transfusions or expected to receive one or more red cell transfusions
- Patients over 16 years of age
- Patients for whom height and weight information is available
- Patients who have consented to participate
Key exclusion criteria (6 listed)
- Patients who are hemodynamically unstable (ongoing bleeding or hemolysis)
- Patients with a known hemolytic anemia (congenital or acquired)
- Patients with a positive Direct Antiglobulin Test (DAT)
- Patients for whom informed consent has not been obtained
- Patients where the hemoglobin concentration increment target is above 2g/dl.
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 |
|---|---|---|
| Calculated red blood cell transfusionThe subjects receive an amount of red blood cells that has been calculated from their body surface area. | Other | Hemoglobin dose |
| Standard red blood cell transfusionThe subjects in this group receive the prescribed number of red blood cell units. | Other | Standard treatment |
Primary outcome
Hemoglobin Concentration Change
Time frame: Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded)
The change in hemoglobin concentration after transfusion was recorded. The change is defined as hemoglobin (g/dl) after transfusion minus hemoglobin (g/dl) before transfusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38780066Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
- Individual participant dataSharing planned: No. If other scientists want to conduct a similar study, we will provide information that are completely anonymized. We are not in contact with any other research group now.
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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.
Tor A Hervig, Professor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calculated red blood cell transfusion and Standard red blood cell transfusion in people with Anemia, run by Haukeland University Hospital at 1 site in Norway.
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 6 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 17 Apr 2025. 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 Norway. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hemoglobin Concentration Change (time frame: Measurements of hemoglobin concentration taken from 30 min to 24hours after transfusion (earliest observation recorded)). 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 NCT01328262, which also lists 1 linked publication.
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 17 Apr 2025.