Transfusion Requirements in Surgical Oncologic Patient

NCT01502215 | Completed Phase 3

• 1 other identifier: 002/11
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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

Conditions

Red Blood Cells Transfusion; Oncologic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hospital Length of Stay

  60 days

Study Arms (2)

Liberal Transfusion Strategy

ACTIVE COMPARATOR

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

Other: Red blood cell transfusion

Restrictive Transfusion Strategy

ACTIVE COMPARATOR

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

Other: Red blood cell transfusion

Interventions

Red blood cell transfusion OTHER

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.

Liberal Transfusion Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cancer after major abdominal surgery requiring post-operative ICU admission
• Adults patients

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, 01246000, Brazil

Location

Related Publications (2)

• Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

  PMID: 41114449 DERIVED

• 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.

  PMID: 34932836 DERIVED

MeSH Terms

Interventions

Erythrocyte Transfusion

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: December 30, 2011
• Study Start: January 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

BR (1)