Clinical trial

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

Name
EOM025/21
Description
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.
Trial arms
Trial start
2022-03-23
Estimated PCD
2023-04-24
Trial end
2023-04-24
Status
Recruiting
Treatment
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.
Arms:
Intervention
Other names:
ferinject
Size
66
Primary endpoint
degree of implementation of the PBM programme
30 days after the intervention or pre-surgery
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}
Updated at
2023-03-31

1 organization