Transfusion Requirements in Critically Ill Oncologic Patient

Last updated: November 5, 2012
Sponsor: Instituto do Cancer do Estado de São Paulo
Overall Status: Trial Status Unknown

Phase

3

Condition

Anemia

Treatment

N/A

Clinical Study ID

NCT01648946
FSB
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 300
Study Start date:
June 01, 2012
Estimated Completion Date:
June 30, 2013

Study 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.

Connect with a study center

  • Instituto do Cancer do Estado de Sao Paulo - Faculdade de Medicina da Universidade de Sao Paulo

    Sao Paulo, 01246-000
    Brazil

    Active - Recruiting

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