.Patient Blood Management Program in Liver Transplantation

Iron Deficiency Anemia Clinical Trial

— PBM-THO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05187637
• Other study ID #: EOM025/21
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: April 24, 2023

Study information

• Verified date: March 2023
• Source: Hospital Universitari de Bellvitge
• Contact: Antoni Sabate, MD
• Phone: +346300836544
• Email: asabatep[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: April 24, 2023
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia

Intervention

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.

Locations

Country	Name	City	State
Spain	HUBellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	security	Safety variables related to iron administration.	immediately after the intervention
Primary	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	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
Secondary	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