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Phase 3
18 Years
N/A
Not Enrolling
Both
Red Blood Cells Transfusion, Oncologic Surgery

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Trial Information


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Composite end-point of mortality and severe complication

Outcome Description:

• 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

Outcome Time Frame:

30 days

Safety Issue:

Yes

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

002/11

NCT ID:

NCT01502215

Start Date:

January 2012

Completion Date:

December 2012

Related Keywords:

  • Red Blood Cells Transfusion
  • Oncologic Surgery

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