Transfusion Requirements in Critically Ill Oncologic Patient

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)

Conditions
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Anemia

Intervention / Treatment
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* Biological: Red blood cell transfusion
* Biological: Red blood cell transfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liberal Transfusion Strategy<br>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. | Biological: Red blood cell transfusion<br>* 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.<br>* Other names: • Oncologic critically ill patient;|
| Active Comparator: Restrictive Transfusion Strategy<br>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. | Biological: Red blood cell transfusion<br>* 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.<br>* Other names: • Oncologic critically ill patient;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare mortality between groups 28 day after ICU admission |  | 28 days after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare length of stay in ICU between groups |  | 90 days | 
| To compare length of stay in hospital between groups |  | 90 days | 
| To compare days free of organ dysfunction between groups |  | 28 days | 
| Adverse effects of transfusion | I. Haemolytic complications after transfusion of RBC; Defined by the clinician on the basis of haemoglobinuria or increased free plasma haemoglobin. II. Anaphylactic/allergic reactions; Defined by the clinician on the basis of mucocutaneous signs and symptoms. III. Transfusion associated acute lung injury (TRALI); defined as: Acute or worsening hypoxaemia ((PaO2/FiO2 < 40 (PaO2 in kPa) or <300 (PaO2 in mmHg) regardless of PEEP) OR > 50% relative increase in FiO2. Occurrence within 6 hours after RBC transfusion AND Acute or worsening pulmonary infiltrates on frontal chest x-ray OR clinical signs of overt pulmonary oedema. IV. Ischaemic events; Defined as either myocardial, cerebral, intestinal or acute limb ischaemia | Followed up until ICU discharge; an expected average of one week | 
| Mortality | All cause 60 day mortality | 60 day | 
| All cause 90 day mortality All cause 90 day mortality Mortality | All cause 90 day mortality | 90 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Strategies of transfusion, Red blood cells, Liberal, Restrictive, Oncologic critically ill patients