Transfusion Requirements in Surgical Oncologic Patient

Phase 3

Completed

• Conditions: Red Blood Cells Transfusion; Oncologic Surgery
• Interventions: Other: Red blood cell transfusion

• Registration Number: NCT01502215
• Lead Sponsor: University of Sao Paulo

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Study Start: 2012-01
• Primary Completion: 2012-10
• Status Verified: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liberal Transfusion Strategy	Red blood cell transfusion	Liberal Group - transfusion when hemoglobin is lower than 9 g/dL. Intervention: Other: Red blood cell transfusion
Restrictive Transfusion Strategy	Red blood cell transfusion	Restrictive Group - transfusion when hemoglobin is lower than 7 g/dL Intervention: Other: Red blood cell transfusion

Primary Outcome Measures

Name	Time	Method
Composite end-point of mortality and severe complication	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

Name	Time	Method
Hospital Length of Stay	60 days	• To compare length of stay in ICU, length of stay in Hospital, health-related quality of life and hospital costs.

Trial Locations

Locations (1)

Instituto do Cancer do Estado de Sao Paulo; 🇧🇷 Sao Paulo, Brazil