Transfusion Requirements in Surgical Oncologic Patient (TRISOP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juliano P Almeida, MD, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01502215
First received: December 29, 2011
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Red Blood Cells Transfusion
Oncologic Surgery
Other: Red blood cell transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Composite end-point of mortality and severe complication [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    • 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 Outcome Measures:
  • Hospital Length of Stay [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    • To compare length of stay in ICU, length of stay in Hospital, health-related quality of life and hospital costs.


Enrollment: 198
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Patients who refused participation in the study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01502215

Locations
Brazil
Instituto do Cancer do Estado de Sao Paulo
Sao Paulo, Brazil, 01246000
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: Juliano P Almeida, MD, Principal Investigator, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01502215     History of Changes
Other Study ID Numbers: 002/11
Study First Received: December 29, 2011
Last Updated: December 4, 2012
Health Authority: Brazil: National Committee of Ethics in Research

ClinicalTrials.gov processed this record on September 15, 2014