Transfusion Requirements in Surgical Oncologic Patient

University of Sao Paulo198 enrolled

Overview

Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative 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 surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

198

Conditions

Red Blood Cells Transfusion Oncologic Surgery

Interventions

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

Red blood cell transfusionOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with cancer after major abdominal surgery requiring post-operative ICU admission * Adults patients Exclusion Criteria: * Age less than 18 year * Hematologic Malignances * Intensive care unit permanence lower than 24 hours * Renal Chronic Failure in Renal Replacement Therapy * Karnofsky Status \< 50 * Previous anemia (hemoglobin lower than 9 g/dL) * Previous thrombocytopenia (platelet number lower than 50.000/mm3) * Previous known coagulopathy * Anticoagulation therapy * Those unable to receive blood transfusion * Patients who refused participation in the study

Outcomes

Primary Outcomes

Composite end-point of mortality and severe complication

• The primary purpose of this study is to compare clinical outcomes after oncologic surgery in patients submitted to different strategies of red blood cell transfusion

Time frame: 30 days

Secondary Outcomes

Hospital Length of Stay

• To compare length of stay in ICU, length of stay in Hospital, health-related quality of life and hospital costs.

Time frame: 60 days