Clinical trial NCT05187637: .Patient Blood Management Program in Liver Transplantation
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron Deficiency Anemia
Keywords: iron deficiency
liver transplantation
intravenous iron
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: University of Barcelona
First posted: 2022-01-12
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cirrhosis of the liver on the waiting list for liver transplantation

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

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

Primary outcomes:
measure: degree of implementation of the PBM programme
timeFrame: 30 days after the intervention or pre-surgery
Secondary outcomes:
measure: Effectiveness
timeFrame: Pre-surgery
measure: Clinical efficacy
timeFrame: immediately after the surgery
Other outcomes:
measure: security
timeFrame: immediately after the intervention
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: HUBellvitge
state: Barcelona
Study officials:
affiliation: Hospital Clinic Universitary
name: Annabel MJ Blasi, MD, PhD
role: STUDY_DIRECTOR
References: