Transfusional Trigger in Post-operative Oncologic Patients in Critical Care

May 15, 2021 updated by: AC Camargo Cancer Center

Transfusional practices evolved significantly over the last decades, but there are still important controversies regarding triggers that should be adopted in different clinical scenarios. Most international guidelines recommend using a hemoglobin (Hb) level around 7,0-8,0g/dL as the value to prompt a transfusion of red blood cell concentrates (RBC). Critical care patients usually are in a hyperdynamic state, working with an elevated cardiac output and compromised organ function. In these patients, the dependency on the arterial content of oxygen is greater, making lower Hb levels more associated with organ disfunction and compromised homeostasis.

With this study the investigators hope to help clinicians to make decisions regarding transfusion of RBCs in critical surgical patients, establishing a transfusional trigger, without exposing patients to unnecessary additional risks, in the scenario involving patients with cancer, in post-operative care.

This is a prospective, randomized, controlled, interventional trial, with the aim of evaluating the impact of restrictive versus liberal transfusional strategy on mortality and severe clinical complications in post-operative oncologic critically ill patients. The primary outcome is mortality in 30 days. The interventions consist in transfusion of RBCs according to the allocation to a liberal or restrictive transfusional strategy. In the restrictive strategy arm patients will receive transfusion of RBCs if the Hb falls to a level equal to or below 7,0g/dL. In the liberal strategy arm patients will receive transfusions if Hb level is below or equal to 9,0g/dL. In both arms patients should receive only one unit of RBC per time, with measurement of Hb level after three hours to evaluate the need for additional units. The strategy should be maintained during intensive care unit (ICU) stay for a maximum of 90 days. In case of a permanence in the ICU for a period longer than 90 days, or if the patient is discharged from the ICU, the transfusional support will be determined by the assisting physicians, independently of the allocated study arm. If the patient returns to the ICU during the 90 days of randomization, then he should go back to receiving transfusions according to the liberal or restrictive strategy in use previously in the ICU.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomization: patients will be randomized in a 1:1 ratio to one of the transfusion strategies, stratified according to age ≤65 years or > 65 years.

Monitoring and follow-up: Study investigators will collect all of the necessary data with the use of specific forms during patient study follow up. In case of transfusional reactions related to the RBC transfusions the ICU team should contact the study investigators to notify the reaction. In cases where the termination of participation in the study occurs before completion of 90 days since randomization, a study investigator will contact the patient for collection of information of the final follow-up form. An independent data and safety monitoring committee (DMSC) will review study data every 6 months to check for the need for suspending or terminating the study.

Blinding: It will not be feasible to mask the assigned transfusion strategy from health care providers. Information regarding frequency of outcome measures will not be available to the study investigators or health care providers, to minimize comparison of outcomes between study groups. Trial statistician will be blinded for the allocation during analysis. The members of the DMSC will remain blinded unless otherwise requested after the interim analysis provides strong indications of one intervention being beneficial or harmful.

Interim analysis: an interim analysis will be performed when a total of 420 patients (half of the expected target sample) has completed 90 days of follow-up. The independent DMSC will recommend interruption of the trial if the difference in the primary outcome measure between groups has a P <0.001 (Haybittle-Peto criterion).

The trial protocol may be temporarily suspended for an individual patient in case of arterial ischemic events (includes stroke, myocardial infarction, unstable angina, mesenteric ischemia, peripheral ischemia) or life-threatening bleeding, at the discretion of the attending physician. The patient may re-enter the trial protocol after stabilization, at the discretion of the attending doctor.

Study Type

Interventional

Enrollment (Anticipated)

840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Patient with a solid tumor and age ≥ 18 years
  • Admission to the ICU due to postoperative care after being submitted to a major surgical procedure (defined as having a duration of three hours or more)
  • Expected ICU stay of more than 24 hours
  • Presenting Hb value of 9,0g/dL or less during ICU stay, within the first 7 days post-surgical procedure

Exclusion Criteria:

  • Hematological malignancy
  • Chronic anemia (defined as presenting Hb ≤9,0g/dL at hospital admission and / or diagnosed hematological disease)
  • Presence of active bleeding at the moment of inclusion in the study (defined as visible bleeding with fall of 2,0g/dL in Hb levels in the last 12 hours or need to reoperate)
  • Transfusion of RBC during the current ICU stay before the inclusion in the study
  • Patient refusal to receive blood transfusions
  • Pregnancy
  • Postoperative care of cardiac surgery or surgery for correction of hip fracture
  • Patients with terminal oncological disease in palliative care
  • Arterial ischemic event in the current hospital stay or in the past twelve months (includes stroke, myocardial infarction, unstable angina, mesenteric ischemia, peripheral ischemia)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Restrictive strategy (arm A)
Transfusion of RBC if Hb ≤7,0g/dL with the aim of maintaining Hb levels between 7,0-9,0g/dL.
Procedure: Restrictive transfusional strategy
Transfusion of Red Blood Concentrates (RBCs) if Hb ≤7,0g/dL with the aim of maintaining Hb levels between 7,0-9,0g/dL.
EXPERIMENTAL: Liberal strategy (arm B)
Transfusion of RBC if Hb ≤9,0g/dL, with the aim of maintaining Hb levels between 9,0-10,0g/dL.
Procedure: Liberal transfusional strategy
Transfusion of RBC if Hb ≤9,0g/dL, with the aim of maintaining Hb levels between 9,0-10,0g/dL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of mortality
Time Frame: 30 days
Mortality 30 days post-randomization
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of mortality at 60 and 90 days post-randomization
Time Frame: 60 and 90 days
Mortality at 60 and 90 days post-randomization
60 and 90 days
Rate of mortality in hospital and ICU admission
Time Frame: 90 days after randomization
Mortality in hospital and ICU admission
90 days after randomization
Number of days alive
Time Frame: 90 days after randomization
Days alive during the 90 days after randomization
90 days after randomization
Duration of ICU and hospital stay
Time Frame: 90 days after randomization
Duration of ICU and hospital stay
90 days after randomization
Number of days alive and out of the hospital during the 90 days after randomization
Time Frame: 90 days after randomization
Days alive and out of the hospital during the 90 days after randomization
90 days after randomization
Rate of organ dysfunction
Time Frame: 90 days after randomization
Total frequency of events: acute renal failure requiring dialysis, acute respiratory distress syndrome with need of mechanical ventilation, hemodynamic instability with need of vasopressor/inotropic therapy, congestive heart failure
90 days after randomization
Number of days alive without mechanical ventilation
Time Frame: 90 days after randomization
Days alive without mechanical ventilation 90 days after randomization
90 days after randomization
Number of days alive without vasopressor/inotropic therapy
Time Frame: 90 days after randomization
Days alive without vasopressor/inotropic therapy 90 days after randomization
90 days after randomization
Number of days alive without dialysis/hemofiltration 90 days after randomization
Time Frame: 90 days after randomization
Days alive without dialysis/hemofiltration
90 days after randomization
Rate of acute ischemic events occurring in the ICU
Time Frame: 90 days after randomization
Total frequency of events: stroke, myocardial infarction, unstable angina, mesenteric ischemia, peripheral ischemia
90 days after randomization
Total frequency of verified infections during ICU admission
Time Frame: 90 days after randomization
Total frequency of verified infections during ICU admission
90 days after randomization
Rate of severe adverse transfusional reactions
Time Frame: 90 days after randomization
Total frequency of events: severe anaphylactic/allergic reactions, acute hemolysis, transfusion-associated lung injury (TRALI), transfusion associated circulatory overload (TACO)
90 days after randomization
Rate of reoperation
Time Frame: 90 days after randomization
Not previously programmed
90 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AC Camargo Cancer Center

Investigators

  • Principal Investigator: Marina P Colella, MD PhD, ACCamargo Cancer Center/ State University of Campinas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2021

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (ACTUAL)

April 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 15, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2789/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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