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Transfusion Requirements in Critically Ill Oncologic Patient (TRICCOP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Instituto do Cancer do Estado de São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Fabricio Sanchez Bergamin, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT01648946
First received: July 19, 2012
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Anemia
Biological: Red blood cell transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)

Resource links provided by NLM:


Further study details as provided by Instituto do Cancer do Estado de São Paulo:

Primary Outcome Measures:
  • To compare mortality between groups 28 day after ICU admission [ Time Frame: 28 days after ICU admission ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare length of stay in ICU between groups [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • To compare length of stay in hospital between groups [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • To compare days free of organ dysfunction between groups [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Adverse effects of transfusion [ Time Frame: Followed up until ICU discharge; an expected average of one week ] [ Designated as safety issue: Yes ]

    I. Haemolytic complications after transfusion of RBC; Defined by the clinician on the basis of haemoglobinuria or increased free plasma haemoglobin.

    II. Anaphylactic/allergic reactions; Defined by the clinician on the basis of mucocutaneous signs and symptoms.

    III. Transfusion associated acute lung injury (TRALI); defined as:

    • Acute or worsening hypoxaemia ((PaO2/FiO2 < 40 (PaO2 in kPa) or <300 (PaO2 in mmHg) regardless of PEEP) OR > 50% relative increase in FiO2.
    • Occurrence within 6 hours after RBC transfusion AND
    • Acute or worsening pulmonary infiltrates on frontal chest x-ray OR clinical signs of overt pulmonary oedema.

    IV. Ischaemic events; Defined as either myocardial, cerebral, intestinal or acute limb ischaemia


  • Mortality [ Time Frame: 60 day ] [ Designated as safety issue: Yes ]
    All cause 60 day mortality

  • All cause 90 day mortality All cause 90 day mortality Mortality [ Time Frame: 90 day ] [ Designated as safety issue: Yes ]
    All cause 90 day mortality


Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Liberal Transfusion Strategy
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 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.
Other Names:
  • • Red blood cells
  • • Transfusion
  • • Liberal
  • • Oncologic critically ill patient
Active Comparator: Restrictive Transfusion Strategy
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.
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.
Other Names:
  • • Red blood cells
  • • Transfusion
  • • Restrictive
  • • Oncologic critically ill patient

Detailed Description:

Blood transfusion is commonly performed in critically ill patients, particularly in oncologic patients. However, there are many studies reporting adverse effects of this intervention and final data on benefits are not available. There are no prospective studies in oncologic patients regarding red blood cell transfusions requirements. There are observational and experimental studies suggesting worse outcomes including higher rates of infection and other clinical complications, maybe higher cancer recurrence, in patients submitted to red blood transfusion. Hemoglobin levels around 9 g/dL are usually recommended although not based in evidence . The investigators purpose is to prospectively evaluate two strategies of transfusion in 400 patients with cancer admitted to intensive care unit for severe clinical condition: a liberal strategy - patients receive blood transfusion when hemoglobin is lower than 9 g/dL since the admission to ICU until ICU discharge; a restrictive strategy - patients receive blood transfusion only when hemoglobin is lower than 7 g/dL.

Clinical outcomes, costs and quality of life will be compared.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults patients with cancer admitted to ICU due to severe clinical condition AND
  • Septic shock diagnosis AND
  • Solid neoplasm AND
  • Written informed consent

Exclusion Criteria:

  • Age less than 18 years OR
  • Leukemia or myelodysplastic syndrome OR
  • Hematologic neoplasm OR
  • Palliative treatment OR
  • Renal Chronic Failure in Renal Replacement Therapy OR
  • Karnofsky Status < 50 OR
  • Previous thrombocytopenia (platelet number lower than 50.000/mm3) OR
  • Previous known coagulopathy OR
  • Life-threatening bleeding OR
  • Documented wish against transfusion OR
  • Patients who refused participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648946

Contacts
Contact: Fabricio S. Bergamin, MD 55-11-82447301 bibergamin@hotmail.com
Contact: Ludhmila A. Hajjar, MD,PHD 55-11-93194401 ludhmila@terra.com.br

Locations
Brazil
Instituto do Cancer do Estado de Sao Paulo - Faculdade de Medicina da Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 01246-000
Contact: Fabricio S. Bergamin, MD    55-11-82447301    bibergamin@hotmail.com   
Principal Investigator: Fabricio S. Bergamin, MD         
Sub-Investigator: Ludhmila A. Hajjar, MD, PhD         
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Investigators
Study Director: Paulo G. Hoff, MD, PhD ICESP - HCFMUSP
  More Information

No publications provided

Responsible Party: Fabricio Sanchez Bergamin, Principal Investigator, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01648946     History of Changes
Other Study ID Numbers: FSB
Study First Received: July 19, 2012
Last Updated: November 5, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto do Cancer do Estado de São Paulo:
Strategies of transfusion
Red blood cells
Liberal
Restrictive
Oncologic critically ill patients

ClinicalTrials.gov processed this record on November 24, 2014