.Patient Blood Management Program in Liver Transplantation

Recruiting

• Conditions: Iron Deficiency Anemia
• Interventions: Drug: intravenous iron

• Registration Number: NCT05187637
• Lead Sponsor: Hospital Universitari de Bellvitge

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

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-12
• Study Start: 2022-03-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31
• Primary Completion: 2023-04-24
• Study Completion: 2023-04-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	intravenous iron	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.

Primary Outcome Measures

Name	Time	Method
degree of implementation of the PBM programme	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

Secondary Outcome Measures

Name	Time	Method
Effectiveness	Pre-surgery	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.
Clinical efficacy	immediately after the surgery	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

Trial Locations

Locations (1)

HUBellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain