Transfusional Trigger in Post-operative Oncologic Patients in Critical Care

NCT04859855 | Unknown DMC

• 1 other identifier: 2789/19
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Transfusion; Oncology; Critical Care; Surgery

Keywords

transfusion; trigger; oncology; post operative; critical care

Outcome Measures

Primary Outcomes (1)

• Rate of mortality

  Mortality 30 days post-randomization

  30 days

Secondary Outcomes (13)

• Rate of mortality at 60 and 90 days post-randomization

  60 and 90 days

• Rate of mortality in hospital and ICU admission

  90 days after randomization

• Number of days alive

  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

  90 days after randomization

Study Arms (2)

Restrictive strategy (arm A)

EXPERIMENTAL

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

Liberal strategy (arm B)

EXPERIMENTAL

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

Interventions

Restrictive transfusional strategy PROCEDURE

Transfusion of Red Blood Concentrates (RBCs) if Hb ≤7,0g/dL with the aim of maintaining Hb levels between 7,0-9,0g/dL.

Restrictive strategy (arm A)

Liberal transfusional strategy PROCEDURE

Transfusion of RBC if Hb ≤9,0g/dL, with the aim of maintaining Hb levels between 9,0-10,0g/dL

Liberal strategy (arm B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hematological malignancy
• Chronic anemia (defined as presenting Hb ≤9,0g/dL at hospital admission and / or diagnosed hematological disease)
• 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)

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

ACCamargoCC

São Paulo, São Paulo, 01509900, Brazil

Location

Related Publications (18)

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• Carson JL, Terrin ML, Noveck H, Sanders DW, Chaitman BR, Rhoads GG, Nemo G, Dragert K, Beaupre L, Hildebrand K, Macaulay W, Lewis C, Cook DR, Dobbin G, Zakriya KJ, Apple FS, Horney RA, Magaziner J; FOCUS Investigators. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.

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  PMID: 11246298 BACKGROUND

• American Society of Anesthesiologists Task Force on Perioperative Blood Management. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*. Anesthesiology. 2015 Feb;122(2):241-75. doi: 10.1097/ALN.0000000000000463. No abstract available.

  PMID: 25545654 BACKGROUND

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MeSH Terms

Conditions

Neoplasms

Study Officials

• Marina P Colella, MD PhD

  ACCamargo Cancer Center/ State University of Campinas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raissa PG de Molla, MD

CONTACT

+5511984359482; raissa.gomes@accamargo.org.br

Marina P Colella, MD, PhD

CONTACT

+5519996917310; marina.colella@accamargo.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 26, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 19, 2021

Record last verified: 2021-04

Locations

BR (1)