.Patient Blood Management Program in Liver Transplantation

NCT ID: NCT05187637

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2023-04-24

Brief 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.

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

Conditions

Iron Deficiency Anemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

intravenous iron

Intervention Type: DRUG

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.

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

ferinject

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Barcelona

OTHER

Sponsor Role: collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: lead

Responsible Party

Lourdes Pérez

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annabel MJ Blasi, MD, PhD

Role: STUDY_DIRECTOR

Hospital Clinic Universitary

Locations

HUBellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Antoni Sabate, MD

Role: CONTACT

asabatep@bellvitgehospital.cat

+346300836544

Lourdes LP Perez, MD,PhD

Role: CONTACT

lourdes.perez@bellvitgehospital.cat

+346300836544

Facility Contacts

Lourdes LP Perez, MD

Role: primary

lourdes.perez@bellvitgehospital.cat

+34630836544

Antoni AS Sabate, MD,PhD

Role: backup

asabatep@ub.edu

+34607074490

Other Identifiers

EOM025/21

Identifier Type: -

Identifier Source: org_study_id