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Transfusion Requirements in Critically Ill Oncologic Patient

NCT01648946 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-11-06

No results posted yet for this study

Summary

Blood transfusion in critical ill patients has been associated to several complications and worse outcome. Particularly in oncologic patients, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due 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 patients. There are no prospective studies comparing outcomes between restrictive or liberal blood transfusion strategy in oncologic critical patients. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic critical patients - liberal or restrictive.

Conditions

Interventions

BIOLOGICAL

Red blood cell transfusion

Red blood cell (RBC) transfusion will be given when hemoglobin falls below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of 1 RBC unit, a repetition of hemoglobin levels is performed; if a patient's hemoglobin level is 9 g/dL or higher, no additional transfusion is necessary.

BIOLOGICAL

Red blood cell transfusion

Red blood cell (RBC) transfusion will be only given when hemoglobin falls below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of 1 RBC unit, a repetition of the hematocrit is performed; if a patient's hemoglobin is 7 g/dL or higher, no additional transfusion is necessary.

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Paulo G. Hoff, MD, PhD · ICESP - HCFMUSP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01648946 on ClinicalTrials.gov