CancerPhase 2HaemOPtimalNCT01116479
Optimal Transfusion in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)
A Phase 2 study testing Blood transfusion in people with Cancer and Anaemia, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
This an open two-arm interventional randomised feasibility study in anaemic patients treated with chemotherapy. Randomisation is performed between two transfusion thresholds: Haemoglobin < 6.0 mmol/l (9.9 g/dL) versus haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males.Primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2010to Dec 2013
- Phase
- Phase 2
- 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
- Documented cancer
- Planned treatment with chemotherapy
- Age older than 18 years
- Informed consent
Who cannot join
- Heart failure (NYHA 3 and 4)
- Prior serious complications to blood transfusion
- Medical conditions that require special considerations for blood transfusion
- Treatment with erythropoiesis-stimulating agents
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Blood bank, Righospitalet
Copenhagen, DK-2100
Dept. of Oncology, Rigshospitalet
Copenhagen, DK-2100
About this study
Official title: Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)
This an open two-arm interventional randomised feasibility study in anaemic patients treated with chemotherapy. Randomisation is performed between two transfusion thresholds: Haemoglobin < 6.0 mmol/l (9.9 g/dL) versus haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males.Primary end-point is quality of life
Read the detailed description
Title:
Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated with Chemotherapy (HaemOPtimal)
Background:
Cancer patients treated with chemotherapy very often become anaemic, which have profound negative impact of their quality of life. Blood transfusions can ameliorate symptoms caused by anaemia. Data are lagging with regard to what threshold should be used when offering blood transfusion.
Aim:
The primary aim is to determine which end-points reflect symptoms caused by anaemia in cancer patients treated with chemotherapy. The secondary aims are to collect data to estimate sample size in a future definitive study and to compare symptom relief using to different transfusion thresholds.
End-points:
- Numeric Rating Scale measuring fatigue, dizziness, palpitations, headache, and dyspnea.
- FACT-G,
- FACT-An (Total anemia scale) including a fatigue subscale
- Patient-assessed WHO performance status
Design:
Open two-arm interventional randomised feasibility study
Intervention:
- Blood transfusion.
- Randomisation between two transfusion thresholds:
Haemoglobin < 6.0 mmol/l (9.9 g/dL) versus Haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males.
Population:
Cancer patients treated with chemotherapy
Inclusion criteria:
- Documented cancer
- Planned treatment with chemotherapy
- Age 18 years or older
- Informed consent
Exclusion criteria:
- Heart failure (NYHA 3 and 4)
- Prior serious complications to blood transfusion
- Medical conditions that require special considerations for blood transfusion
- Treatment with erythropoiesis-stimulating agents.
Number of patients:
Transfusion of at least 30 patients in each intervention arm. An estimated number of 90 patients will be randomised in each arm (180 in total) as a third of included patients are expected to require transfusion.
- Being tested
- Blood transfusion
- Keywords
- Anaemia, transfusion, cancer, chemotherapy, Quality of life
- Medical subject headings
- Neoplasms, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionOther
Blood transfusion with packed erythrocytes
| Study group | Role | What they receive |
|---|---|---|
| Haemoglobin (<6.0 mmol/l) | Active comparator | Blood transfusion thresholds:Haemoglobin < 6.0 mmol/l (9.9 g/dL) Receives: Other: Blood transfusion |
| Haemoglobin (< normal range) | Experimental | Blood transfusion threshold: Haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males Receives: Other: Blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status
Patient assessed FACT-G (Functional Assessment of Therapy in General), FACT-An (Functional Assessment of Therapy in Anaemia), Numeric Rating Scale on symptoms of anaemia (fatigue, dizziness, dyspnea, palpitations, headache) and performance status before each cycle of chemotherapy, before transfusion and daily in seven days after transfusion
Measured: Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion
Secondary outcomes (1)
Safety and transfusion complications
Frequency of complications to blood transfusion (need for termination of transfusion due to complications, chills, fever, hives, drop in blood pressure, dyspnea, other)
Measured: during or after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Sorensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Morten Sorensen, MD, Phd, Principal investigator, Dept. of Oncology, Righospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116479
- Sponsor's protocol ID
- H-1-2009-109
- Acronym
- HaemOPtimal
- Status last verified
- Nov 2014
- First submitted
- 28 Apr 2010
- Last updated
- 5 Nov 2014
- 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 34932836
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated With Chemotherapy (HaemOPtimal)
- ClinicalTrials.gov ID
- NCT01116479
- Acronym / sponsor ID
- HaemOPtimal / H-1-2009-109
- Keywords
- Anaemia, transfusion, cancer, chemotherapy, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 May 2010 (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 an open two-arm interventional randomised feasibility study in anaemic patients treated with chemotherapy. Randomisation is performed between two transfusion thresholds: Haemoglobin < 6.0 mmol/l (9.9 g/dL) versus haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males.Primary end-point is quality of life
Detailed description
Title:
Randomised Feasibility Study of Optimal Transfusion Thresholds in Anaemic Cancer Patients Treated with Chemotherapy (HaemOPtimal)
Background:
Cancer patients treated with chemotherapy very often become anaemic, which have profound negative impact of their quality of life. Blood transfusions can ameliorate symptoms caused by anaemia. Data are lagging with regard to what threshold should be used when offering blood transfusion.
Aim:
The primary aim is to determine which end-points reflect symptoms caused by anaemia in cancer patients treated with chemotherapy. The secondary aims are to collect data to estimate sample size in a future definitive study and to compare symptom relief using to different transfusion thresholds.
End-points:
- Numeric Rating Scale measuring fatigue, dizziness, palpitations, headache, and dyspnea.
- FACT-G,
- FACT-An (Total anemia scale) including a fatigue subscale
- Patient-assessed WHO performance status
Design:
Open two-arm interventional randomised feasibility study
Intervention:
- Blood transfusion.
- Randomisation between two transfusion thresholds:
Haemoglobin < 6.0 mmol/l (9.9 g/dL) versus Haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males.
Population:
Cancer patients treated with chemotherapy
Inclusion criteria:
- Documented cancer
- Planned treatment with chemotherapy
- Age 18 years or older
- Informed consent
Exclusion criteria:
- Heart failure (NYHA 3 and 4)
- Prior serious complications to blood transfusion
- Medical conditions that require special considerations for blood transfusion
- Treatment with erythropoiesis-stimulating agents.
Number of patients:
Transfusion of at least 30 patients in each intervention arm. An estimated number of 90 patients will be randomised in each arm (180 in total) as a third of included patients are expected to require transfusion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haemoglobin (<6.0 mmol/l) | Active comparator | Other: Blood transfusionBlood transfusion thresholds:Haemoglobin < 6.0 mmol/l (9.9 g/dL) |
| Haemoglobin (< normal range) | Experimental | Other: Blood transfusionBlood transfusion threshold: Haemoglobin < 7.1 mmol/l (11.7 g/dL) for female and 8.1 mmol/l (13.4 g/dL) for males |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented cancer
- Planned treatment with chemotherapy
- Age older than 18 years
- Informed consent
Key exclusion criteria (4 listed)
- Heart failure (NYHA 3 and 4)
- Prior serious complications to blood transfusion
- Medical conditions that require special considerations for blood transfusion
- Treatment with erythropoiesis-stimulating agents
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 |
|---|---|---|
| Blood transfusionBlood transfusion with packed erythrocytes | Other | Haemoglobin (< normal range), Haemoglobin (<6.0 mmol/l) |
Primary outcome
FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status
Time frame: Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion
Patient assessed FACT-G (Functional Assessment of Therapy in General), FACT-An (Functional Assessment of Therapy in Anaemia), Numeric Rating Scale on symptoms of anaemia (fatigue, dizziness, dyspnea, palpitations, headache) and performance status before each cycle of chemotherapy, before transfusion and daily in seven days after transfusion
1 secondary outcome
Safety and transfusion complications
Time frame: during or after transfusion
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- 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.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Morten Sorensen, MD, Phd principal investigator
Dept. of Oncology, Righospitalet, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Blood transfusion in people with Cancer and Anaemia, 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 4 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 5 Nov 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low accrual). 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?
FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status (time frame: Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion). 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 NCT01116479, which also lists 2 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 5 Nov 2014.