Transfusion Requirements in Surgical Oncologic Patient (TRISOP)

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 Overview

• Status: Completed
• Conditions: Red Blood Cells Transfusion; Oncologic Surgery
• Intervention / Treatment: Other: Red blood cell transfusion; Other: Red blood cell transfusion

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01246000
    • Instituto do Cancer do Estado de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 29, 2011
• First Submitted That Met QC Criteria: December 29, 2011
• First Posted (Estimate): December 30, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2012
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 002/11