Transfusion Requirements in Surgical Oncologic Patient (TRISOP)

University of Sao Paulo

Status and phase: Completed; Phase 3

Conditions: Red Blood Cells Transfusion; Oncologic Surgery

Treatments: Other: Red blood cell transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01502215

002/11

Details and patient eligibility

About

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

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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198 participants in 2 patient groups

Liberal Transfusion Strategy

Active Comparator group

Description:

Liberal Group - transfusion when hemoglobin is lower than 9 g/dL. Intervention: Other: Red blood cell transfusion

Treatment:

Other: Red blood cell transfusion

Other: Red blood cell transfusion

Restrictive Transfusion Strategy

Active Comparator group

Description:

Restrictive Group - transfusion when hemoglobin is lower than 7 g/dL Intervention: Other: Red blood cell transfusion

Treatment:

Other: Red blood cell transfusion

Other: Red blood cell transfusion