Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04859855
Status:
UNKNOWN
Last Update Posted:
2021-05-19
First Post:
2021-04-22
Brief Title:
Transfusional Trigger in Post-operative Oncologic Patients in Critical Care
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Transfusional Trigger in Post-operative Oncologic Patients in Critical Care
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 70-80gdL 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 70gdL In the liberal strategy arm patients will receive transfusions if Hb level is below or equal to 90gdL 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
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 70gdL In the liberal strategy arm patients will receive transfusions if Hb level is below or equal to 90gdL 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
Detailed Description:
Randomization patients will be randomized in a 11 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 0001 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
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 0001 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None