Transfusion Requirements After Orthotopic Liver Transplantation (TROLL)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Anemia	Behavioral: Red blood cell transfusion	Phase 2

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	A Randomized, Controlled Pilot Trial of Transfusion Requirements After Orthotopic Liver
Study Start Date :	November 2011
Estimated Primary Completion Date :	November 2012
Estimated Study Completion Date :	November 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Composite of death, graft loss and renal failure [ Time Frame: 30 days after randomization ]

Secondary Outcome Measures :

1. Renal function [ Time Frame: 30 days after randomization ]
   Renal function will be assessed by estimated glomerular filtration rate

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Armin D Goralczyk, Dr.	+49 551 398490	agoralczyk@med.uni-goettingen.de
Contact: Aiman Obed, Prof.	+49 551 398490	aobed@med.uni-goettingen.de

Locations

Germany
University Medical Center Göttingen	Not yet recruiting
Göttingen, Niedersachsen, Germany, 37075
Contact: Armin D Goralczyk, Dr. +49 551 398490 agoralczyk@med.uni-goettingen.de
Sub-Investigator: Aiman Obed, Prof.
Principal Investigator: Thomas Lorf, Dr.

Sponsors and Collaborators

University Medical Center Goettingen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Armin Goralczyk, Dr., University Medical Center Goettingen
ClinicalTrials.gov Identifier:	NCT01435746 History of Changes
Other Study ID Numbers:	TROLL11
First Posted:	September 19, 2011
Last Update Posted:	September 19, 2011
Last Verified:	September 2011

Keywords provided by Armin Goralczyk, University Medical Center Goettingen:

liver transplantation; intensive care; red blood cell transfusion