Transfusion Requirements After Orthotopic Liver Transplantation

NCT ID: NCT01435746

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Liberal 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.

Group Type: EXPERIMENTAL

Red blood cell transfusion

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type: 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.

Interventions

Red blood cell transfusion

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Goettingen

OTHER

Sponsor Role: lead

Responsible Party

Karsten Gavenis

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Center Göttingen

Göttingen, Lower Saxony, Germany

Countries

Germany

Other Identifiers

TROLL11

Identifier Type: -

Identifier Source: org_study_id