Transfusion Requirements in Surgical Oncologic Patient

Study Overview
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Brief Summary
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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

Conditions
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Red Blood Cells Transfusion, Oncologic Surgery

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


Participation Criteria
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Eligibility Criteria
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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

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liberal Transfusion Strategy<br>Liberal Group - transfusion when hemoglobin is lower than 9 g/dL. Intervention: Other: Red blood cell transfusion | Other: Red blood cell transfusion<br>* 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.<br>|
| Active Comparator: Restrictive Transfusion Strategy<br>Restrictive Group - transfusion when hemoglobin is lower than 7 g/dL Intervention: Other: Red blood cell transfusion | Other: Red blood cell transfusion<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | • To compare length of stay in ICU, length of stay in Hospital, health-related quality of life and hospital costs. | 60 days |