Transfusion Requirements After Orthotopic Liver Transplantation (TROLL)

August 4, 2022 updated by: Karsten Gavenis, University Medical Center Goettingen

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Niedersachsen
      • Göttingen, Niedersachsen, Germany, 37075
        • University Medical Center Göttingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: 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.
ACTIVE_COMPARATOR: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of death, graft loss and renal failure
Time Frame: 30 days after randomization
30 days after randomization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Goettingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 16, 2011

First Posted (ESTIMATE)

September 19, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TROLL11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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