Transfusion Requirements After Orthotopic Liver Transplantation

NCT01435746 | Withdrawn

• 1 other identifier: TROLL11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

liver transplantation; intensive care; red blood cell transfusion

Outcome Measures

Primary Outcomes (1)

• Composite of death, graft loss and renal failure

  30 days after randomization

Secondary Outcomes (1)

• Renal function

  30 days after randomization

Study Arms (2)

Liberal Transfusion

EXPERIMENTAL

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

Conservative Transfusion

ACTIVE COMPARATOR

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

Interventions

Red blood cell transfusion BEHAVIORAL

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.

Conservative Transfusion; Liberal Transfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing liver transplantation
• Patients considered to have euvolemia after initial treatment by attending physicians

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Sites (1)

University Medical Center Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

MeSH Terms

Conditions

Anemia

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 19, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2013
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

DE (1)