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Anemia | Transfusion Requirements in Critically Ill Oncologic Patient

Anemia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Anemia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:Red blood cell transfusionRed 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 transfusionRed 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Liberal Transfusion StrategyRed 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.

Restrictive Transfusion StrategyRed 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.

Study Status

Unknown status

Start Date: June 2012

Completed Date: June 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: To compare mortality between groups 28 day after ICU admission

Secondary Outcome: To compare length of stay in ICU between groups

Study sponsors, principal investigator, and references

Principal Investigator: Paulo G. Hoff, MD, PhD

Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01648946

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, Leão 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.

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