Transfusion Requirements in Surgical Oncologic Patient

Red Blood Cells Transfusion Clinical Trial

— TRISOP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502215
• Other study ID #: 002/11
• Status: Completed
• Phase: Phase 3
• First received: December 29, 2011
• Last updated: December 4, 2012
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Oncologic Surgery
• Red Blood Cells Transfusion

Intervention

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.
• 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

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite end-point of mortality and severe complication	• 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	30 days	Yes
Secondary	Hospital Length of Stay	• To compare length of stay in ICU, length of stay in Hospital, health-related quality of life and hospital costs.	60 days	Yes