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Transfusion Requirements After Orthotopic Liver Transplantation (TROLL)

U

University Medical Center Goettingen

Status

Withdrawn

Conditions

Anemia

Treatments

Behavioral: Red blood cell transfusion

Study type

Interventional

Funder types

Other

Identifiers

NCT01435746
TROLL11

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Liberal Transfusion
Experimental group
Description:
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.
Treatment:
Behavioral: Red blood cell transfusion
Conservative Transfusion
Active Comparator group
Description:
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.
Treatment:
Behavioral: Red blood cell transfusion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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