NCT01648946

Transfusion Requirements in Critically Ill Oncologic Patient

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia

Interventions

Type	Name	Description
BIOLOGICAL	Red blood cell transfusion	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	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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-07-25
• Last updated: 2012-11-06

Locations

1 site across 1 country: Brazil