Transfusion Requirements in Critically Ill Oncologic Patient

Anemia Clinical Trial

— TRICCOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01648946
• Other study ID #: FSB
• Status: Recruiting
• Phase: Phase 3
• First received: July 19, 2012
• Last updated: November 5, 2012
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2012
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Fabricio S. Bergamin, MD
• Phone: 55-11-82447301
• Email: bibergamin[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de Sao Paulo - Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare mortality between groups 28 day after ICU admission		28 days after ICU admission	Yes
Secondary	To compare length of stay in ICU between groups		90 days	Yes
Secondary	To compare length of stay in hospital between groups		90 days	Yes
Secondary	To compare days free of organ dysfunction between groups		28 days	Yes
Secondary	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	Yes
Secondary	Mortality	All cause 60 day mortality	60 day	Yes
Secondary	All cause 90 day mortality All cause 90 day mortality Mortality	All cause 90 day mortality	90 day	Yes