.Patient Blood Management Program in Liver Transplantation (PBM-THO)

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.

Study Overview

• Status: Recruiting
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Drug: intravenous iron

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 Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

• Study Contact: Name: Antoni Sabate, MD; Phone Number: +346300836544; Email: asabatep@bellvitgehospital.cat
• Study Contact Backup: Name: Lourdes LP Perez, MD,PhD; Phone Number: +346300836544; Email: lourdes.perez@bellvitgehospital.cat

Study Locations

• Spain
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • HUBellvitge
      • Contact: Lourdes LP Perez, MD; Phone Number: +34630836544; Email: lourdes.perez@bellvitgehospital.cat
      • Contact: Antoni AS Sabate, MD,PhD; Phone Number: +34607074490; Email: asabatep@ub.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis of the liver on the waiting list for liver transplantation

Description

Inclusion Criteria:

• liver cirrhosis on the liver transplant waiting list
• haemoglobin lower than 11.5g/dL
• transferrin saturation index below 40%
• ferritin below 800mcg/L

Exclusion Criteria:

• refusal to participate
• Known hypersensitivity to Ferinject
• current infection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: intravenous iron; 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.; Other Names: ferinject
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days after the intervention or pre-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	immediately after the surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
security	Safety variables related to iron administration.	immediately after the intervention

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Collaborators: University of Barcelona
• Investigators: Study Director: Annabel MJ Blasi, MD, PhD, Hospital Clinic Universitary

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Anticipated): April 24, 2023
• Study Completion (Anticipated): April 24, 2023

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: liver transplantation; iron deficiency; intravenous iron
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: EOM025/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No