Transfusion Requirements After Orthotopic Liver Transplantation

Study Overview
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Brief Summary
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The objective of this trial is to evaluate different transfusion strategies in patients after liver transplantation. Patients in the experimental arm will be given red blood cell (RBC) transfusion according to a liberal strategy, i. e., transfusions should be given, when hemoglobin concentration falls below 10 g/dl, and hemoglobin concentration should be maintained between 10 and 12 g/dl. Patients in the control arm will be given red blood cell (RBC) transfusion according to a restrictive strategy, i. e., transfusions should be given, when hemoglobin concentration falls below 8 g/dl, and hemoglobin concentration should be maintained between 8 and 10 g/dl.

Official Title
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A Randomized, Controlled Pilot Trial of Transfusion Requirements After Orthotopic Liver

Conditions
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Anemia

Intervention / Treatment
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* Behavioral: Red blood cell transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing liver transplantation Patients considered to have euvolemia after initial treatment by attending physicians Exclusion Criteria: Patients age 18 or less Patients undergoing combined liver-kidney transplantation Patients requiring renal replacement therapy before liver transplantation for longer than two weeks Inability to receive blood products Patient with active blood loss at the time of enrollment Pregnancy Imminent death

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liberal Transfusion<br>Patients in the liberal transfusion group will receive red blood cell transfusions when their hemoglobin concentration drops below 10 g/dl. The aim should be to reach a hemoglobin concentration between 10 and 12 g/dl. | Behavioral: Red blood cell transfusion<br>* The intervention of this trial is the regime of red blood cell transfusion. The control group will receive red blood cell transfusions according to a conservative regime, whereas the experimental group will receive red blood cell transfusion according to a liberal transfusion regime.<br>|
| Active Comparator: Conservative Transfusion<br>Patients in the conservative transfusion group will receive red blood cell transfusions when their hemoglobin concentration drops below 8 g/dl. The aim should be to reach a hemoglobin concentration between 8 and 10 g/dl. | Behavioral: Red blood cell transfusion<br>* The intervention of this trial is the regime of red blood cell transfusion. The control group will receive red blood cell transfusions according to a conservative regime, whereas the experimental group will receive red blood cell transfusion according to a liberal transfusion regime.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death, graft loss and renal failure |  | 30 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | Renal function will be assessed by estimated glomerular filtration rate | 30 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver transplantation, intensive care, red blood cell transfusion