Transfusion Requirements After Orthotopic Liver Transplantation

Not Applicable

Withdrawn

• Conditions: Anemia
• Interventions: Behavioral: Red blood cell transfusion

• Registration Number: NCT01435746
• Lead Sponsor: University Medical Center Goettingen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Study Start: 2011-11
• Primary Completion: 2012-11
• Study Completion: 2013-11
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative Transfusion	Red blood cell transfusion	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.
Liberal Transfusion	Red blood cell transfusion	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.

Primary Outcome Measures

Name	Time	Method
Composite of death, graft loss and renal failure	30 days after randomization

Secondary Outcome Measures

Name	Time	Method
Renal function	30 days after randomization	Renal function will be assessed by estimated glomerular filtration rate

Trial Locations

Locations (1)

University Medical Center Göttingen; 🇩🇪 Göttingen, Niedersachsen, Germany