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Transfusion Requirements in Surgical Oncologic Patient

NCT ID: NCT01502215

Last Updated: 2012-12-05

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-12-31

Brief Summary

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Blood transfusion during perioperative period in patients undergoing to major surgery has been associated to several postoperative complications. Particularly in oncologic surgery, red blood cell transfusion has been investigated as a factor of worse outcome and cancer recurrence due to postoperative 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 surgery. There are no prospective studies comparing outcomes between restrictive or liberal of blood transfusion strategy in oncologic surgery. This study is a prospective and randomized study comparing clinical outcomes between two strategies of transfusion in oncologic surgery - liberal or restrictive

Detailed Description

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Conditions

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Red Blood Cells Transfusion Oncologic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Liberal Transfusion Strategy

Liberal Group - transfusion when hemoglobin is lower than 9 g/dL. Intervention: Other: Red blood cell transfusion

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type OTHER

Red blood cell (RBC) transfusion will be given when hemoglobin fall below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hemoglobin levels is performed;if a patient's hemoglobin is 9 g/dL or higher, no additional transfusion is necessary.

Restrictive Transfusion Strategy

Restrictive Group - transfusion when hemoglobin is lower than 7 g/dL Intervention: Other: Red blood cell transfusion

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type OTHER

Red blood cell (RBC) transfusion will be only given when hemoglobin fall below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hemoglobin 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 fall below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hemoglobin levels is performed;if a patient's hemoglobin is 9 g/dL or higher, no additional transfusion is necessary.

Intervention Type OTHER

Red blood cell transfusion

Red blood cell (RBC) transfusion will be only given when hemoglobin fall below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hemoglobin 7 g/dL or higher, no additional transfusion is necessary

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with cancer after major abdominal surgery requiring post-operative ICU admission
* Adults patients

Exclusion Criteria

* Age less than 18 year
* Hematologic Malignances
* Intensive care unit permanence lower than 24 hours
* Renal Chronic Failure in Renal Replacement Therapy
* Karnofsky Status \< 50
* Previous anemia (hemoglobin lower than 9 g/dL)
* Previous thrombocytopenia (platelet number lower than 50.000/mm3)
* Previous known coagulopathy
* Anticoagulation therapy
* Those unable to receive blood transfusion
* Patients who refused participation in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Juliano P Almeida, MD, Principal Investigator

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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)

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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002/11

Identifier Type: -

Identifier Source: org_study_id