Iron Deficiency AnemiaPBM-THONCT05187637
.Patient Blood Management Program in Liver Transplantation
An observational study of Iron Deficiency Anemia, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
Transfusion management improvement programs, generally known as patient blood management (PBM) programs, are based on a set of perioperative measures aimed at improving clinical outcomes by avoiding unnecessary exposure to blood components. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- intravenous iron
- Type of treatment
- Injection or infusion
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 23 Mar 2022to 24 Apr 2023
- Phase
- Observational
- 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
Study population: Patients with cirrhosis of the liver on the waiting list for liver transplantation
Who may be able to join
- liver cirrhosis on the liver transplant waiting list
- haemoglobin lower than 11.5g/dL
- transferrin saturation index below 40%
- ferritin below 800mcg/L
Who cannot join
- refusal to participate
- Known hypersensitivity to Ferinject
- current infection
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
HUBellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Lourdes LP Perez, MD, +34630836544, lourdes.perez@bellvitgehospital.cat
Antoni AS Sabate, MD,PhD, +34607074490, asabatep@ub.edu
About this study
Official title: Analysis of the Application of a Patient Blood Management Program in Liver Transplantation Through Intravenous Iron Treatment in Patients on the Liver Transplant Waiting List
Transfusion management improvement programs, generally known as patient blood management (PBM) programs, are based on a set of perioperative measures aimed at improving clinical outcomes by avoiding unnecessary exposure to blood components.
In a recent series of liver transplants (LT) performed in Spanish centers belonging to the Spanish Liver Transplant Society, despite optimal hemostasis management and preservation of the vena cava, around 20% of patients required massive transfusion (considered as the administration of 6 or more red blood cell concentrates intraoperatively). In addition, 63% of the patients were transfused with at least one packed red cells during the operation.
By correcting the iron deficiency in patients who meet the criteria of the anemia study (transferrin saturation less than 20%), we could improve the hemoglobin level, which would allow a wider margin for the transfusion of red cell concentrates.
Read the detailed description
This is a prospective observational multicenter study to evaluate the efficacy of iron administration in patients candidates to LT. Inclusion criteria Patients with Hb < 11.5 g/dL + and transferrin saturation index < 40%+ferritina <800mcg/L will receive Fe carboxymaltose iv* *Ganzoni formula modified (total iron dose = [actual body weight × (11.5-actual Hb)] × 2.4 + 500), and represent the intervention group. Those patients with Hb < 11.5 g/dL and transferrin saturation index > 40% will constitute the control group. The Intraoperative managed protocol was standardized within groups and Teams. Demographic and liver function test after iron administration will be registered; perioperative transfusion data will be recorded. Recruitment, treatment and follow-up will be conducted by monitored by an independent audit to assure the quality of data. Specific Data Unit not related to the participated Teams will do statistical analysis. The primary outcome is the feasibility of apply the first pillar of the patient blood management programs (PBM) in LT candidates. Secondary outcomes are the response rate (increase in Hb > 1 g/dL) to the intervention, and red blood cell requirements in both, intervention and control group
- Conditions
- Iron Deficiency Anemia
- Being tested
- intravenous iron
- Keywords
- iron deficiency, liver transplantation, intravenous iron
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous ironDrug
Also called ferinject
One dose of intravenous iron carboxymaltose calculated according to ganzoni's formula. If after thirty days of the first dose, a second dose of 500mg will be administered if the patient continues to meet the inclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Patients on the waiting list for liver transplantation with haemoglobin less than 11.5g/dL and transferrin saturation index less than 40% with ferritin less than 800mcg/L, which are considered iron deficiency susceptible to respond to intravenous iron administration. Receives: Drug: intravenous iron | |
| Control | Patients on the waiting list for liver transplantation in the same period of the intervention cohort, with haemoglobin less than 11.5g/dL and transferrin saturation index more than 40%, which are considered of non susceptibles for iron supplement alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of implementation of the PBM programme
To assess the degree of implementation of the PBM Programme in its first pillar in patients with iron deficiency anaemia, determining the degree and quality of implementation of the PBM programme in liver transplantation, measured as the percentage of patients complying with the iron correction protocol
Measured: 30 days after the intervention or pre-surgery
Secondary outcomes (2)
Effectiveness
Percentage of responding patients, understanding positive response as an increase in haemoglobin ≥ 1 g/dl from inclusion in the study to the day of transplantation.
Measured: Pre-surgery
Clinical efficacy
Percentage of patients requiring transfusion and intraoperative massive transfusion and the number of red blood cell concentrates received per patient, compared to a cohort, adjusted for the characteristics of the included population, of patients transplanted in the same period with anaemia of inflammatory cause
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start23 Mar 2022
- Primary completion24 Apr 2023 (estimated)
- Study completion24 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Principal investigator, Lourdes Pérez, Hospital Universitari de Bellvitge
- Investigators
- Annabel MJ Blasi, MD, PhD, Study director, Hospital Clinic Universitary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187637
- Sponsor's protocol ID
- EOM025/21
- Acronym
- PBM-THO
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2021
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perez L, Blasi A, Gutierrez R, Caballero M, Perez J, Zarragoikoetxea I, Vidal J, Salvador P, Ojinaga G, Duque P, Bosca A, Carmona PI, Colmenero J, Colomina MJ, Llaurado S, Sabate A. Correction of iron deficiency anemia in liver transplantation. Preliminary study. Med Clin (Barc). 2025 Nov;165(5):107136. doi: 10.1016/j.medcli.2025.107136. Epub 2025 Aug 26. English, Spanish.
PubMed 40865175
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Application of a Patient Blood Management Program in Liver Transplantation Through Intravenous Iron Treatment in Patients on the Liver Transplant Waiting List
- ClinicalTrials.gov ID
- NCT05187637
- Acronym / sponsor ID
- PBM-THO / EOM025/21
- Conditions
- Iron Deficiency Anemia
- Keywords
- iron deficiency, liver transplantation, intravenous iron
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 24 Apr 2023 (estimated)
- Study completion
- 24 Apr 2023 (estimated)
- First posted
- 12 Jan 2022 (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.
Transfusion management improvement programs, generally known as patient blood management (PBM) programs, are based on a set of perioperative measures aimed at improving clinical outcomes by avoiding unnecessary exposure to blood components.
In a recent series of liver transplants (LT) performed in Spanish centers belonging to the Spanish Liver Transplant Society, despite optimal hemostasis management and preservation of the vena cava, around 20% of patients required massive transfusion (considered as the administration of 6 or more red blood cell concentrates intraoperatively). In addition, 63% of the patients were transfused with at least one packed red cells during the operation.
By correcting the iron deficiency in patients who meet the criteria of the anemia study (transferrin saturation less than 20%), we could improve the hemoglobin level, which would allow a wider margin for the transfusion of red cell concentrates.
Detailed description
This is a prospective observational multicenter study to evaluate the efficacy of iron administration in patients candidates to LT. Inclusion criteria Patients with Hb < 11.5 g/dL + and transferrin saturation index < 40%+ferritina <800mcg/L will receive Fe carboxymaltose iv* *Ganzoni formula modified (total iron dose = [actual body weight × (11.5-actual Hb)] × 2.4 + 500), and represent the intervention group. Those patients with Hb < 11.5 g/dL and transferrin saturation index > 40% will constitute the control group. The Intraoperative managed protocol was standardized within groups and Teams. Demographic and liver function test after iron administration will be registered; perioperative transfusion data will be recorded. Recruitment, treatment and follow-up will be conducted by monitored by an independent audit to assure the quality of data. Specific Data Unit not related to the participated Teams will do statistical analysis. The primary outcome is the feasibility of apply the first pillar of the patient blood management programs (PBM) in LT candidates. Secondary outcomes are the response rate (increase in Hb > 1 g/dL) to the intervention, and red blood cell requirements in both, intervention and control group
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Drug: intravenous ironPatients on the waiting list for liver transplantation with haemoglobin less than 11.5g/dL and transferrin saturation index less than 40% with ferritin less than 800mcg/L, which are considered iron deficiency susceptible to respond to intravenous iron administration. |
| Control | – | –Patients on the waiting list for liver transplantation in the same period of the intervention cohort, with haemoglobin less than 11.5g/dL and transferrin saturation index more than 40%, which are considered of non susceptibles for iron supplement alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis of the liver on the waiting list for liver transplantation
Key inclusion criteria (4 listed)
- liver cirrhosis on the liver transplant waiting list
- haemoglobin lower than 11.5g/dL
- transferrin saturation index below 40%
- ferritin below 800mcg/L
Key exclusion criteria (3 listed)
- refusal to participate
- Known hypersensitivity to Ferinject
- current infection
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 |
|---|---|---|
| intravenous ironAlso: ferinjectOne dose of intravenous iron carboxymaltose calculated according to ganzoni's formula. If after thirty days of the first dose, a second dose of 500mg will be administered if the patient continues to meet the inclusion criteria. | Drug | Intervention |
Primary outcome
degree of implementation of the PBM programme
Time frame: 30 days after the intervention or pre-surgery
To assess the degree of implementation of the PBM Programme in its first pillar in patients with iron deficiency anaemia, determining the degree and quality of implementation of the PBM programme in liver transplantation, measured as the percentage of patients complying with the iron correction protocol
2 secondary outcomes
Effectiveness
Time frame: Pre-surgery
Clinical efficacy
Time frame: immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 40865175Perez L, Blasi A, Gutierrez R, Caballero M, Perez J, Zarragoikoetxea I, Vidal J, Salvador P, Ojinaga G, Duque P, Bosca A, Carmona PI, Colmenero J, Colomina MJ, Llaurado S, Sabate A. Correction of iron deficiency anemia in liver transplantation. Preliminary study. Med Clin (Barc). 2025 Nov;165(5):107136. doi: 10.1016/j.medcli.2025.107136. Epub 2025 Aug 26. English, Spanish.
- Individual participant dataSharing planned: Undecided
Related trials for Iron Deficiency Anemia
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
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.
Annabel MJ Blasi, MD, PhD study director
Hospital Clinic Universitary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia, run by Hospital Universitari de Bellvitge 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 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: status not confirmed, as of the sponsor's last update on 31 Mar 2023. 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 Antoni Sabate, MD (+346300836544, asabatep@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of implementation of the PBM programme (time frame: 30 days after the intervention or pre-surgery). 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 NCT05187637, 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 31 Mar 2023.