Transfusional Trigger in Post-operative Oncologic Patients in Critical Care

Last updated on July 2021

Recruitment

Recruitment Status: Not yet recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Critical Care
Oncology
Surgery
Transfusion

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Transfusion of RBCs according to allocation in two arms: Restrictive strategy (arm A): transfusion if Hb ?7,0g/dL with the aim of maintaining Hb levels between 7,0-9,0g/dL. Liberal strategy (arm B): transfusion if Hb?9,0g/dL, with the aim of maintaining Hb levels between 9,0-10,0g/dL. In both arms patients should receive one unit of RBC per time, and Hb should be monitored after 3 hours to check for the need of additional transfusion. The strategy should be maintained during the entire ICU stay, for a maximum of 90 days. In case of 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 study. 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. Patients will receive pre-storage leukodepleted and irradiated RBCs.Masking: Single (Outcomes Assessor)Masking Description: 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 they request otherwise after the interim analysis provides strong indications of one intervention being beneficial or harmful.Primary Purpose: Supportive Care

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

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.

Tracking Information

NCT #: NCT04859855
Collaborators: Not Provided
Investigators: Principal Investigator: Marina P Colella, MD PhD ACCamargo Cancer Center/ State University of Campinas