Surgery Clinical Trial
Official title:
Transfusional Trigger in Post-operative Oncologic Patients in Critical Care
NCT number | NCT04859855 |
Other study ID # | 2789/19 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2021 |
Est. completion date | August 2022 |
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.
Status | Not yet recruiting |
Enrollment | 840 |
Est. completion date | August 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Brazil | ACCamargoCC | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
AC Camargo Cancer Center |
Brazil,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of mortality | Mortality 30 days post-randomization | 30 days | |
Secondary | Rate of mortality at 60 and 90 days post-randomization | Mortality at 60 and 90 days post-randomization | 60 and 90 days | |
Secondary | Rate of mortality in hospital and ICU admission | Mortality in hospital and ICU admission | 90 days after randomization | |
Secondary | Number of days alive | Days alive during the 90 days after randomization | 90 days after randomization | |
Secondary | Duration of ICU and hospital stay | Duration of ICU and hospital stay | 90 days after randomization | |
Secondary | Number of days alive and out of the hospital during the 90 days after randomization | Days alive and out of the hospital during the 90 days after randomization | 90 days after randomization | |
Secondary | Rate of organ dysfunction | 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 | |
Secondary | Number of days alive without mechanical ventilation | Days alive without mechanical ventilation 90 days after randomization | 90 days after randomization | |
Secondary | Number of days alive without vasopressor/inotropic therapy | Days alive without vasopressor/inotropic therapy 90 days after randomization | 90 days after randomization | |
Secondary | Number of days alive without dialysis/hemofiltration 90 days after randomization | Days alive without dialysis/hemofiltration | 90 days after randomization | |
Secondary | Rate of acute ischemic events occurring in the ICU | Total frequency of events: stroke, myocardial infarction, unstable angina, mesenteric ischemia, peripheral ischemia | 90 days after randomization | |
Secondary | Total frequency of verified infections during ICU admission | Total frequency of verified infections during ICU admission | 90 days after randomization | |
Secondary | Rate of severe adverse transfusional reactions | Total frequency of events: severe anaphylactic/allergic reactions, acute hemolysis, transfusion-associated lung injury (TRALI), transfusion associated circulatory overload (TACO) | 90 days after randomization | |
Secondary | Rate of reoperation | Not previously programmed | 90 days after randomization |
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