NCT01648946

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

July 19, 2012

Last Update Submit

November 5, 2012

Conditions

Anemia

Keywords

Strategies of transfusionRed blood cellsLiberalRestrictiveOncologic critically ill patients

Outcome Measures

Primary Outcomes (1)

  • To compare mortality between groups 28 day after ICU admission

    28 days after ICU admission

Secondary Outcomes (6)

  • 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

    Followed up until ICU discharge; an expected average of one week

  • Mortality

    60 day

  • +1 more secondary outcomes

Study Arms (2)

Liberal Transfusion Strategy

ACTIVE COMPARATOR

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

Restrictive Transfusion Strategy

ACTIVE COMPARATOR

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

Interventions

Red blood cell transfusionBIOLOGICAL

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.

Also known as: • Red blood cells, • Transfusion, • Liberal, • Oncologic critically ill patient
Liberal Transfusion Strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

Related Publications (4)

  • 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.

    PMID: 20940381RESULT

  • 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(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

    PMID: 41114449DERIVED

  • 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.

    PMID: 38780066DERIVED

  • 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.

    PMID: 34932836DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Erythrocyte TransfusionErythrocyte CountBlood Transfusion

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBiological TherapyTherapeuticsBlood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Paulo G. Hoff, MD, PhD

    ICESP - HCFMUSP

    STUDY DIRECTOR

Central Study Contacts

Fabricio S. Bergamin, MD

CONTACT

55-11-82447301bibergamin@hotmail.com

Ludhmila A. Hajjar, MD,PHD

CONTACT

55-11-93194401ludhmila@terra.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 25, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

BR(1)