Transfusion Requirements After Orthotopic Liver Transplantation

Anemia Clinical Trial

— TROLL  

Official title:

A Randomized, Controlled Pilot Trial of Transfusion Requirements After Orthotopic Liver

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01435746
• Other study ID #: TROLL11
• Status: Withdrawn
• Phase: N/A
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: August 2022
• Source: University Medical Center Goettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

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.

Locations

Country	Name	City	State
Germany	University Medical Center Göttingen	Göttingen	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of death, graft loss and renal failure		30 days after randomization
Secondary	Renal function	Renal function will be assessed by estimated glomerular filtration rate	30 days after randomization