Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)
Blood transfusion is commonly performed in critically ill patients, particularly in
oncologic patients. However, there are many studies reporting adverse effects of this
intervention and final data on benefits are not available. There are no prospective studies
in oncologic patients regarding red blood cell transfusions requirements. There are
observational and experimental studies suggesting worse outcomes including higher rates of
infection and other clinical complications, maybe higher cancer recurrence, in patients
submitted to red blood transfusion. Hemoglobin levels around 9 g/dL are usually recommended
although not based in evidence . The investigators purpose is to prospectively evaluate two
strategies of transfusion in 400 patients with cancer admitted to intensive care unit for
severe clinical condition: a liberal strategy - patients receive blood transfusion when
hemoglobin is lower than 9 g/dL since the admission to ICU until ICU discharge; a
restrictive strategy - patients receive blood transfusion only when hemoglobin is lower than
7 g/dL.
Clinical outcomes, costs and quality of life will be compared.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare mortality between groups 28 day after ICU admission
28 days after ICU admission
Yes
Paulo G. Hoff, MD, PhD
Study Director
ICESP - HCFMUSP
Brazil: National Committee of Ethics in Research
FSB
NCT01648946
June 2012
June 2013
Name | Location |
---|