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Transfusion Requirements After Orthotopic Liver Transplantation (TROLL)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Armin Goralczyk, University Medical Center Goettingen.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01435746
First Posted: September 19, 2011
Last Update Posted: September 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Armin Goralczyk, University Medical Center Goettingen
September 14, 2011
September 19, 2011
September 19, 2011
November 2011
November 2012   (Final data collection date for primary outcome measure)
Composite of death, graft loss and renal failure [ Time Frame: 30 days after randomization ]
Same as current
No Changes Posted
Renal function [ Time Frame: 30 days after randomization ]
Renal function will be assessed by estimated glomerular filtration rate
Same as current
Not Provided
Not Provided
 
Transfusion Requirements After Orthotopic Liver Transplantation
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Anemia
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.
  • 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.
    Intervention: Behavioral: Red blood cell transfusion
  • 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.
    Intervention: Behavioral: Red blood cell transfusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
November 2013
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01435746
TROLL11
No
Not Provided
Not Provided
Armin Goralczyk, University Medical Center Goettingen
University Medical Center Goettingen
Not Provided
Not Provided
University Medical Center Goettingen
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP