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Transfusion Requirements in Critically Ill Oncologic Patient

NCT ID: NCT01648946

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anemia

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type BIOLOGICAL

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.

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.

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Other Intervention Names

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• Red blood cells • Transfusion • Liberal • Oncologic critically ill patient • Red blood cells • Transfusion • Restrictive • Oncologic critically ill patient

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Fabricio Sanchez Bergamin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulo G. Hoff, MD, PhD

Role: STUDY_DIRECTOR

ICESP - HCFMUSP

Locations

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Instituto do Cancer do Estado de Sao Paulo - Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Fabricio S. Bergamin, MD

Role: CONTACT

Phone: 55-11-82447301

Email: [email protected]

Ludhmila A. Hajjar, MD,PHD

Role: CONTACT

Phone: 55-11-93194401

Email: [email protected]

Facility Contacts

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Fabricio S. Bergamin, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 20940381 (View on PubMed)

Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10:CD002042. doi: 10.1002/14651858.CD002042.pub6.

Reference Type DERIVED
PMID: 41114449 (View on PubMed)

Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.

Reference Type DERIVED
PMID: 38780066 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34932836 (View on PubMed)

Other Identifiers

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FSB

Identifier Type: -

Identifier Source: org_study_id