AnemiaANHEMOGNCT04757909
Detection of Anemizations in Primary Care.
A study testing Monthly Haemoglobinometry in people with Anemia and Red Blood Cell Transfusion, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Objective: To evaluate the effect of the use of the hemoglobinometer in primary care on the clinical results of patients with chronic anemia. Methods: The ANHEMOG study is a randomized controlled trial with two parallel arms, intervention and control. It was approved at december 11, 2017. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Anemia, Red Blood Cell Transfusion
- What is being tested?
- Monthly Haemoglobinometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2017to Dec 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People over 40 years old
- Had received 2 or more red blood cell transfusions due to chronic disease, during a year.
- The health provider in Primary Care is the Institut Català de la Salut.
Who cannot join
- Presenting kidney failure on hemodialysis treatment.
- Being in palliative care situation
- Presenting a moderate-severe cognitive impairment, with a Pfeiffer scale score higher than 5.
- Not having a caregiver able to detect signs of decompensation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Detection of Anemizations in Primary Care Using Hemoglobinometer: Randomized Clinical Trial Protocol.
Objective: To evaluate the effect of the use of the hemoglobinometer in primary care on the clinical results of patients with chronic anemia.
Methods: The ANHEMOG study is a randomized controlled trial with two parallel arms, intervention and control. It was approved at december 11, 2017. The study randomizes 138 patients with chronic anemia. In the intervention arm, a monthly capillary hemoglobin measurement will be performed with a hemoglobinometer. If a decrease in hemoglobin concentration is detected, an existing transfusion circuit will be followed. Social, demographic and quality of life variables will be collected from all participants.
Read more
Hypothesis:
The results of the research will have an impact on people with chronic anemia who would receive red blood cell transfusion when needed without delay. The improvement in the times of action would reduce decompensations from chronic diseases, visits to the emergency room and hospital admissions, and therefore would improve the quality of life of these patients. Furthermore, the management of the different interventions by the Case Management Nurse (EGC), in this regard, improves the current fragmentation of the different levels of care.
- Conditions
- Anemia, Red Blood Cell Transfusion
- Being tested
- Monthly Haemoglobinometry
- Keywords
- Haemoglobinometry, Primary Care Nursing,, Advanced Practice Nursing
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly HaemoglobinometryDiagnostic test
Monthly measurement of capillary hemoglobin with non-invasive techniques in primary health care.
Inclusion in a transfusion circuit with referral to a hospital day hospital if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Monthly Haemoglobinometry | Experimental | Not described Receives: Diagnostic Test: Monthly Haemoglobinometry |
| Routine monitoring | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of hospital admissions
Anual mean of hospital admissions caused by haemoglobin concentration decline.
Measured: 6 and 12 months.
Mean Number of visits to the emergency room
Anual mean of visits to the emergency room caused by haemoglobin concentration decline.
Measured: 6 and 12 months.
Secondary outcomes (2)
Quality of life self-assessment.
WHOQOL-BREF questionnaire.
Measured: 6 and 12 months.
Satisfaction with the intervention.
Ad-hoc questionnaire.
Measured: 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start30 Mar 2017
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
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.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757909
- Sponsor's protocol ID
- 4R17/013
- Other IDs
- 4R18/08, 4R17/013
- Acronym
- ANHEMOG
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be sent to publication in the next months
Publications
Trenado-Luengo B, Garcia-Sierra R, Wilke Trinxant MA, Diaz Mondelo E, Toran-Monserrat P. Hemoglobinometry at the point of care with activation of a hospital transfusion pathway versus usual care for the early detection of anaemia in primary care: the ANHEMOG randomized controlled trial. BMC Prim Care. 2026 Mar 10;27(1):141. doi: 10.1186/s12875-026-03262-0.
PubMed 41808002Radford 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 38780066Luengo BT, Garcia-Sierra R, Trinxant MAW, Mondelo ED, Baseda RM, Blanch MML, Del Pilar Montero Alia M, Toran-Monserrat P. Early detection of anaemia in primary care with haemoglobinometry: ANHEMOG clinical trial protocol. BMC Fam Pract. 2021 Oct 8;22(1):199. doi: 10.1186/s12875-021-01548-z.
PubMed 34625027
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Anemizations in Primary Care Using Hemoglobinometer: Randomized Clinical Trial Protocol.
- ClinicalTrials.gov ID
- NCT04757909
- Acronym / sponsor ID
- ANHEMOG / 4R17/013
- Conditions
- Anemia, Red Blood Cell Transfusion
- Keywords
- Haemoglobinometry, Primary Care Nursing,, Advanced Practice Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Feb 2021 (actual)
- 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.
Objective: To evaluate the effect of the use of the hemoglobinometer in primary care on the clinical results of patients with chronic anemia.
Methods: The ANHEMOG study is a randomized controlled trial with two parallel arms, intervention and control. It was approved at december 11, 2017. The study randomizes 138 patients with chronic anemia. In the intervention arm, a monthly capillary hemoglobin measurement will be performed with a hemoglobinometer. If a decrease in hemoglobin concentration is detected, an existing transfusion circuit will be followed. Social, demographic and quality of life variables will be collected from all participants.
Hypothesis:
The results of the research will have an impact on people with chronic anemia who would receive red blood cell transfusion when needed without delay. The improvement in the times of action would reduce decompensations from chronic diseases, visits to the emergency room and hospital admissions, and therefore would improve the quality of life of these patients. Furthermore, the management of the different interventions by the Case Management Nurse (EGC), in this regard, improves the current fragmentation of the different levels of care.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monthly Haemoglobinometry | Experimental | Diagnostic Test: Monthly Haemoglobinometry |
| Routine monitoring | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- People over 40 years old
- Had received 2 or more red blood cell transfusions due to chronic disease, during a year.
- The health provider in Primary Care is the Institut Català de la Salut.
Key exclusion criteria (4 listed)
- Presenting kidney failure on hemodialysis treatment.
- Being in palliative care situation
- Presenting a moderate-severe cognitive impairment, with a Pfeiffer scale score higher than 5.
- Not having a caregiver able to detect signs of decompensation.
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 |
|---|---|---|
| Monthly HaemoglobinometryMonthly measurement of capillary hemoglobin with non-invasive techniques in primary health care. Inclusion in a transfusion circuit with referral to a hospital day hospital if necessary. | Diagnostic test | Monthly Haemoglobinometry |
Primary outcome
Mean Number of hospital admissions
Time frame: 6 and 12 months.
Anual mean of hospital admissions caused by haemoglobin concentration decline.
Mean Number of visits to the emergency room
Time frame: 6 and 12 months.
Anual mean of visits to the emergency room caused by haemoglobin concentration decline.
2 secondary outcomes
Quality of life self-assessment.
Time frame: 6 and 12 months.
Satisfaction with the intervention.
Time frame: 6 and 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 41808002Trenado-Luengo B, Garcia-Sierra R, Wilke Trinxant MA, Diaz Mondelo E, Toran-Monserrat P. Hemoglobinometry at the point of care with activation of a hospital transfusion pathway versus usual care for the early detection of anaemia in primary care: the ANHEMOG randomized controlled trial. BMC Prim Care. 2026 Mar 10;27(1):141. doi: 10.1186/s12875-026-03262-0.
- 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.
- Derived from this study: PubMed 34625027Luengo BT, Garcia-Sierra R, Trinxant MAW, Mondelo ED, Baseda RM, Blanch MML, Del Pilar Montero Alia M, Toran-Monserrat P. Early detection of anaemia in primary care with haemoglobinometry: ANHEMOG clinical trial protocol. BMC Fam Pract. 2021 Oct 8;22(1):199. doi: 10.1186/s12875-021-01548-z.
- Individual participant dataSharing planned: Yes. Study protocol will be sent to publication in the next months
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly Haemoglobinometry in people with Anemia and Red Blood Cell Transfusion, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 17 Feb 2021. 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 Spain. 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?
Contact Boris Trenado Luengo, RN (0034 93384 24 25, btrenado.mn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of hospital admissions (time frame: 6 and 12 months.). The study lists 2 primary outcomes in all. 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 NCT04757909, 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 17 Feb 2021.