Transfusion Requirements After Orthotopic Liver Transplantation (TROLL)
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ClinicalTrials.gov Identifier: NCT01435746 |
Recruitment Status
: Unknown
Verified September 2011 by Armin Goralczyk, University Medical Center Goettingen.
Recruitment status was: Not yet recruiting
First Posted
: September 19, 2011
Last Update Posted
: September 19, 2011
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Condition or disease | Intervention/treatment | Phase |
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Anemia | Behavioral: Red blood cell transfusion | Phase 2 |
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 |
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.
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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.
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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.
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- Composite of death, graft loss and renal failure [ Time Frame: 30 days after randomization ]
- Renal function [ Time Frame: 30 days after randomization ]Renal function will be assessed by estimated glomerular filtration rate

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435746
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 |
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. |
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 Key Record Dates |
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 |