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Clinical Trials/NCT01502215
NCT01502215
Completed
Phase 3

Transfusion Requirements in Surgical Oncologic Patient

University of Sao Paulo1 site in 1 country198 target enrollmentJanuary 2012

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Red Blood Cells Transfusion
Sponsor
University of Sao Paulo
Enrollment
198
Locations
1
Primary Endpoint
Composite end-point of mortality and severe complication
Status
Completed
Last Updated
13 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Juliano P Almeida, MD, Principal Investigator

Principal Investigator

University of Sao Paulo

Eligibility Criteria

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

Outcomes

Primary Outcomes

Composite end-point of mortality and severe complication

Time Frame: 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 Outcomes

  • Hospital Length of Stay(60 days)

Study Sites (1)

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