Clinical Trials Logo

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.


Clinical Trial 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 < 20% 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 > 20% 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 Design


Related Conditions & MeSH terms


NCT number NCT05187637
Study type Observational
Source Hospital Universitari de Bellvitge
Contact Antoni Sabate, MD
Phone +346300836544
Email [email protected]
Status Not yet recruiting
Phase
Start date January 2, 2022
Completion date December 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT02282553 - Gastric Capsule Examination for Iron Deficiency Anaemia N/A
Recruiting NCT04913649 - Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients Phase 4
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Completed NCT01307007 - Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding Phase 2
Completed NCT00982007 - Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA) Phase 3
Completed NCT00198848 - Iron Supplementation Among Adolescent Girls in India N/A
Completed NCT01166451 - The Anemia Control Program: High or Low Iron Supplementation N/A
Recruiting NCT03893045 - A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects Phase 3
Recruiting NCT03817957 - Postoperative i.v. Iron Substitution in Patients With Diagnosed Iron Deficiency Phase 3
Completed NCT03618914 - Anemia and Inflammation
Completed NCT03940430 - Lactoferrin Versus Ferrous Sulfate in Management of Iron Deficiency Anemia Among Female Medical Ain Shams Students Phase 2/Phase 3
Enrolling by invitation NCT03897673 - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas N/A
Active, not recruiting NCT04778072 - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects N/A
Completed NCT03237065 - Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Phase 3
Completed NCT05153278 - IV Iron Versus Standard Treatment for Iron Deficiency Anemia in the Emergency Department
Completed NCT03238911 - Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Phase 3
Completed NCT02175888 - The Optimization of Bioavailability From Iron Supplements: Study 1 N/A
Completed NCT01864161 - Endovenous Versus Liposomal Iron in CKD Phase 4
Completed NCT01224535 - Improving Iron Status of Children: Potential of Amaranth N/A