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Transfusion Requirements After Orthotopic Liver Transplantation (TROLL)

This study is not yet open for participant recruitment.
Verified September 2011 by University Medical Center Goettingen
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:

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
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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013