Transfusion Requirements in Critically Ill Oncologic Patient (TRICCOP)

Instituto do Cancer do Estado de São Paulo

Status and phase: Unknown; Phase 3

Conditions: Anemia

Treatments: Biological: Red blood cell transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01648946

FSB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Liberal Transfusion Strategy

Active Comparator group

Description:

Red blood cell (RBC) transfusion will be given when hemoglobin falls below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of 1 RBC unit, a repetition of hemoglobin levels is performed; if a patient's hemoglobin level is 9 g/dL or higher, no additional transfusion is necessary.

Treatment:

Biological: Red blood cell transfusion

Biological: Red blood cell transfusion

Restrictive Transfusion Strategy

Active Comparator group

Description:

Red blood cell (RBC) transfusion will be only given when hemoglobin falls below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of 1 RBC unit, a repetition of the hematocrit is performed; if a patient's hemoglobin is 7 g/dL or higher, no additional transfusion is necessary.

Treatment:

Biological: Red blood cell transfusion

Biological: Red blood cell transfusion