Transfusion Requirements in Critically Ill Oncologic Patient (TRICCOP)

Transfusion Requirements in Critical Clinical Oncologic Patients: a Phase 3 Randomized Controlled Clinical Trial (TRICCOP STUDY)

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.

Study Overview

• Status: Unknown
• Conditions: Anemia
• Intervention / Treatment: Biological: Red blood cell transfusion; Biological: Red blood cell transfusion

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01246-000
    • Recruiting
    • Instituto do Cancer do Estado de Sao Paulo - Faculdade de Medicina da Universidade de Sao Paulo
    • Contact: Fabricio S. Bergamin, MD; Phone Number: 55-11-82447301; Email: bibergamin@hotmail.com
    • Principal Investigator: Fabricio S. Bergamin, MD
    • Sub-Investigator: Ludhmila A. Hajjar, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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; • Oncologic critically ill patient; • Restrictive
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 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; 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; • Oncologic critically ill patient; • Restrictive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare mortality between groups 28 day after ICU admission	28 days after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare length of stay in ICU between groups		90 days
To compare length of stay in hospital between groups		90 days
To compare days free of organ dysfunction between groups		28 days
Adverse effects of transfusion	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	Followed up until ICU discharge; an expected average of one week
Mortality	All cause 60 day mortality	60 day
All cause 90 day mortality All cause 90 day mortality Mortality	All cause 90 day mortality	90 day

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Investigators: Study Director: Paulo G. Hoff, MD, PhD, ICESP - HCFMUSP

Publications and helpful links

General Publications

• Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
• 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, Leao 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Estimate): November 6, 2012
• Last Update Submitted That Met QC Criteria: November 5, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Red blood cells; Restrictive; Strategies of transfusion; Liberal; Oncologic critically ill patients
• Other Study ID Numbers: FSB