We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transfusion Requirements in Surgical Oncologic Patient (TRISOP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01502215
First Posted: December 30, 2011
Last Update Posted: December 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juliano P Almeida, MD, Principal Investigator, University of Sao Paulo
  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
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Juliano P Almeida, MD, Principal Investigator, University of Sao Paulo:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Hospital Length of Stay [ Time Frame: 60 days ]
    • 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502215


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

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
First Submitted: December 29, 2011
First Posted: December 30, 2011
Last Update Posted: December 5, 2012
Last Verified: December 2012