Transfusion Requirements in Critically Ill Oncologic Patient (TRICCOP)

• ClinicalTrials.gov Identifier: NCT01648946
• Recruitment Status: Unknown
• First Posted: July 25, 2012
• Last Update Posted: November 6, 2012
• Sponsor: Instituto do Cancer do Estado de São Paulo
• Information provided by (Responsible Party): Fabricio Sanchez Bergamin, Instituto do Cancer do Estado de São Paulo

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Anemia	Biological: Red blood cell transfusion	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)
• Study Start Date: June 2012
• Estimated Primary Completion Date: June 2013
• Estimated Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. To compare mortality between groups 28 day after ICU admission [ Time Frame: 28 days after ICU admission ]

Secondary Outcome Measures :

1. To compare length of stay in ICU between groups [ Time Frame: 90 days ]
2. To compare length of stay in hospital between groups [ Time Frame: 90 days ]
3. To compare days free of organ dysfunction between groups [ Time Frame: 28 days ]
4. Adverse effects of transfusion [ Time Frame: Followed up until ICU discharge; an expected average of one week ]

   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

5. Mortality [ Time Frame: 60 day ]
   All cause 60 day mortality
6. All cause 90 day mortality All cause 90 day mortality Mortality [ Time Frame: 90 day ]
   All cause 90 day mortality

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications of Results:

Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leão WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.

• 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
• First Posted: July 25, 2012
• Last Update Posted: November 6, 2012
• Last Verified: November 2012

Keywords provided by Fabricio Sanchez Bergamin, Instituto do Cancer do Estado de São Paulo:

Strategies of transfusion; Red blood cells; Liberal; Restrictive; Oncologic critically ill patients