Transfusion Requirements in Surgical Oncologic Patient

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

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Key information

Conditions

Red Blood Cells Transfusion Oncologic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Time frame: 60 days
- To compare length of stay in ICU, length of stay in Hospital, health-related quality of life and hospital costs.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Acronym: TRISOP

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Dec 30, 2011
Registry last updated: Dec 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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