Clinical trial NCT01648946: Transfusion Requirements in Critically Ill Oncologic Patient
Official title: Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anemia
Keywords: Strategies of transfusion
Red blood cells
Liberal
Restrictive
Oncologic critically ill patients
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Blood transfusion in critical ill patients has been associated to several complications and worse outcome. Particularly in oncologic patients, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due impairment of cellular immunity. Although red blood cell transfusion has decreased in worldwide clinical practice, this issue still remains a matter of controversy in oncologic patients. There are no prospective studies comparing outcomes between restrictive or liberal blood transfusion strategy in oncologic critical patients. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic critical patients - liberal or restrictive.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults patients with cancer admitted to ICU due to severe clinical condition AND
* Septic shock diagnosis AND
* Solid neoplasm AND
* Written informed consent

Exclusion Criteria:

* Age less than 18 years OR
* Leukemia or myelodysplastic syndrome OR
* Hematologic neoplasm OR
* Palliative treatment OR
* Renal Chronic Failure in Renal Replacement Therapy OR
* Karnofsky Status \< 50 OR
* Previous thrombocytopenia (platelet number lower than 50.000/mm3) OR
* Previous known coagulopathy OR
* Life-threatening bleeding OR
* Documented wish against transfusion OR
* Patients who refused participation in the study

Primary outcomes:
measure: To compare mortality between groups 28 day after ICU admission
timeFrame: 28 days after ICU admission
Secondary outcomes:
measure: To compare length of stay in ICU between groups
timeFrame: 90 days
measure: To compare length of stay in hospital between groups
timeFrame: 90 days
measure: To compare days free of organ dysfunction between groups
timeFrame: 28 days
measure: Adverse effects of transfusion
timeFrame: Followed up until ICU discharge; an expected average of one week
measure: Mortality
timeFrame: 60 day
measure: All cause 90 day mortality All cause 90 day mortality Mortality
timeFrame: 90 day
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: ICESP - HCFMUSP
name: Paulo G. Hoff, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.