Oncologic Surgery, Red Blood Cells Transfusion
Conditions
Brief summary
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
Interventions
OTHERRed blood cell transfusion
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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite end-point of mortality and severe complication | 30 days | • 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | 60 days | • To compare length of stay in ICU, length of stay in Hospital, health-related quality of life and hospital costs. |
Countries
Brazil
Outcome results
None listed