Transfusion Requirements After Orthotopic Liver Transplantation (TROLL)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2011 by University Medical Center Goettingen.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

Armin Goralczyk, University Medical Center Goettingen

ClinicalTrials.gov Identifier:

NCT01435746

First received: September 14, 2011

Last updated: September 16, 2011

Last verified: September 2011

History of Changes

Purpose

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	Intervention	Phase
Anemia	Behavioral: Red blood cell transfusion	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Randomized, Controlled Pilot Trial of Transfusion Requirements After Orthotopic Liver

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Liver Transplantation

U.S. FDA Resources

Further study details as provided by University Medical Center Goettingen:

Primary Outcome Measures:

Composite of death, graft loss and renal failure [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Renal function [ Time Frame: 30 days after randomization ] [ Designated as safety issue: No ]
Renal function will be assessed by estimated glomerular filtration rate


Estimated Enrollment:	60
Study Start Date:	November 2011
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435746

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

No publications provided


Responsible Party:	Armin Goralczyk, Dr., University Medical Center Goettingen
ClinicalTrials.gov Identifier:	NCT01435746 History of Changes
Other Study ID Numbers:	TROLL11
Study First Received:	September 14, 2011
Last Updated:	September 16, 2011
Health Authority:	Germany: Ethics Commission

Keywords provided by University Medical Center Goettingen:


liver transplantation intensive care red blood cell transfusion

ClinicalTrials.gov processed this record on March 03, 2015

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