Transfusion Requirements After Orthotopic Liver Transplantation

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01435746

Acronym

TROLL

Enrollment

Registered

2011-09-19

Start date

2011-11-30

Completion date

2013-11-30

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

liver transplantation, intensive care, red blood cell transfusion

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.

Interventions

BEHAVIORALRed 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Composite of death, graft loss and renal failure	30 days after randomization

Secondary

Measure	Time frame	Description
Renal function	30 days after randomization	Renal function will be assessed by estimated glomerular filtration rate

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026