NCT05187637

.Patient Blood Management Program in Liver Transplantation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 66 (estimated)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-23
• Primary completion: 2023-04-24
• Completion: 2023-04-24
• First posted: 2022-01-12
• Last updated: 2023-03-31

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study