Transfusional Trigger in Post-operative Oncologic Patients in Critical Care
NCT ID: NCT04859855
Last Updated: 2021-05-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
840 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-05-31
Study Completion Date
2022-08-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Transfusion
Oncology
Critical Care
Surgery
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Outcome Assessors
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.
Study Groups
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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.
Group Type
EXPERIMENTAL
Restrictive transfusional strategy
Intervention Type
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.
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.
Group Type
EXPERIMENTAL
Liberal transfusional strategy
Intervention Type
PROCEDURE
Transfusion of RBC if Hb ≤9,0g/dL, with the aim of maintaining Hb levels between 9,0-10,0g/dL
Interventions
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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.
Intervention Type
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
Intervention Type
PROCEDURE
Eligibility Criteria
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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
* 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)
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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AC Camargo Cancer Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Marina P Colella, MD PhD
Role: PRINCIPAL_INVESTIGATOR
ACCamargo Cancer Center/ State University of Campinas
Locations
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ACCamargoCC
São Paulo, São Paulo, Brazil
Site Status
Countries
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Brazil
Central Contacts
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Facility Contacts
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References
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Carson JL, Duff A, Poses RM, Berlin JA, Spence RK, Trout R, Noveck H, Strom BL. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet. 1996 Oct 19;348(9034):1055-60. doi: 10.1016/S0140-6736(96)04330-9.
Reference Type
BACKGROUND
Carson JL, Noveck H, Berlin JA, Gould SA. Mortality and morbidity in patients with very low postoperative Hb levels who decline blood transfusion. Transfusion. 2002 Jul;42(7):812-8. doi: 10.1046/j.1537-2995.2002.00123.x.
Reference Type
BACKGROUND
Carson JL, Stanworth SJ, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2016 Oct 12;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub4.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
de Almeida JP, Vincent JL, Galas FR, de Almeida EP, Fukushima JT, Osawa EA, Bergamin F, Park CL, Nakamura RE, Fonseca SM, Cutait G, Alves JI, Bazan M, Vieira S, Sandrini AC, Palomba H, Ribeiro U Jr, Crippa A, Dalloglio M, Diz Mdel P, Kalil Filho R, Auler JO Jr, Rhodes A, Hajjar LA. Transfusion requirements in surgical oncology patients: a prospective, randomized controlled trial. Anesthesiology. 2015 Jan;122(1):29-38. doi: 10.1097/ALN.0000000000000511.
Reference Type
BACKGROUND
Holst LB, Haase N, Wetterslev J, Wernerman J, Guttormsen AB, Karlsson S, Johansson PI, Aneman A, Vang ML, Winding R, Nebrich L, Nibro HL, Rasmussen BS, Lauridsen JR, Nielsen JS, Oldner A, Pettila V, Cronhjort MB, Andersen LH, Pedersen UG, Reiter N, Wiis J, White JO, Russell L, Thornberg KJ, Hjortrup PB, Muller RG, Moller MH, Steensen M, Tjader I, Kilsand K, Odeberg-Wernerman S, Sjobo B, Bundgaard H, Thyo MA, Lodahl D, Maerkedahl R, Albeck C, Illum D, Kruse M, Winkel P, Perner A; TRISS Trial Group; Scandinavian Critical Care Trials Group. Lower versus higher hemoglobin threshold for transfusion in septic shock. N Engl J Med. 2014 Oct 9;371(15):1381-91. doi: 10.1056/NEJMoa1406617. Epub 2014 Oct 1.
Reference Type
BACKGROUND
Hovaguimian F, Myles PS. Restrictive versus Liberal Transfusion Strategy in the Perioperative and Acute Care Settings: A Context-specific Systematic Review and Meta-analysis of Randomized Controlled Trials. Anesthesiology. 2016 Jul;125(1):46-61. doi: 10.1097/ALN.0000000000001162.
Reference Type
BACKGROUND
Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.
Reference Type
BACKGROUND
Hebert PC, Yetisir E, Martin C, Blajchman MA, Wells G, Marshall J, Tweeddale M, Pagliarello G, Schweitzer I; Transfusion Requirements in Critical Care Investigators for the Canadian Critical Care Trials Group. Is a low transfusion threshold safe in critically ill patients with cardiovascular diseases? Crit Care Med. 2001 Feb;29(2):227-34. doi: 10.1097/00003246-200102000-00001.
Reference Type
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.
Reference Type
BACKGROUND
Shander A, Javidroozi M, Naqvi S, Aregbeyen O, Caylan M, Demir S, Juhl A. An update on mortality and morbidity in patients with very low postoperative hemoglobin levels who decline blood transfusion (CME). Transfusion. 2014 Oct;54(10 Pt 2):2688-95; quiz 2687. doi: 10.1111/trf.12565. Epub 2014 Feb 17.
Reference Type
BACKGROUND
Taira R, Satake M, Momose S, Hino S, Suzuki Y, Murokawa H, Uchida S, Tadokoro K. Residual risk of transfusion-transmitted hepatitis B virus (HBV) infection caused by blood components derived from donors with occult HBV infection in Japan. Transfusion. 2013 Jul;53(7):1393-404. doi: 10.1111/j.1537-2995.2012.03909.x. Epub 2012 Oct 4.
Reference Type
BACKGROUND
Vieira PCM, Lamarao LM, Amaral CEM, Correa ASM, de Lima MSM, Barile KADS, de Almeida KLD, Sortica VA, Kayath AS, Burbano RMR. Residual risk of transmission of human immunodeficiency virus and hepatitis C virus infections by blood transfusion in northern Brazil. Transfusion. 2017 Aug;57(8):1968-1976. doi: 10.1111/trf.14146. Epub 2017 Jun 7.
Reference Type
BACKGROUND
Wang JK, Klein HG. Red blood cell transfusion in the treatment and management of anaemia: the search for the elusive transfusion trigger. Vox Sang. 2010 Jan;98(1):2-11. doi: 10.1111/j.1423-0410.2009.01223.x. Epub 2009 Aug 4.
Reference Type
BACKGROUND
Weiskopf RB, Feiner J, Hopf H, Viele MK, Watson JJ, Lieberman J, Kelley S, Toy P. Heart rate increases linearly in response to acute isovolemic anemia. Transfusion. 2003 Feb;43(2):235-40. doi: 10.1046/j.1537-2995.2003.00302.x.
Reference Type
BACKGROUND
Weiskopf RB, Viele MK, Feiner J, Kelley S, Lieberman J, Noorani M, Leung JM, Fisher DM, Murray WR, Toy P, Moore MA. Human cardiovascular and metabolic response to acute, severe isovolemic anemia. JAMA. 1998 Jan 21;279(3):217-21. doi: 10.1001/jama.279.3.217.
Reference Type
BACKGROUND
Wu WC, Schifftner TL, Henderson WG, Eaton CB, Poses RM, Uttley G, Sharma SC, Vezeridis M, Khuri SF, Friedmann PD. Preoperative hematocrit levels and postoperative outcomes in older patients undergoing noncardiac surgery. JAMA. 2007 Jun 13;297(22):2481-8. doi: 10.1001/jama.297.22.2481.
Reference Type
BACKGROUND
Fossaluza V, Diniz JB, Pereira Bde B, Miguel EC, Pereira CA. Sequential allocation to balance prognostic factors in a psychiatric clinical trial. Clinics (Sao Paulo). 2009;64(6):511-8. doi: 10.1590/s1807-59322009000600005.
Reference Type
BACKGROUND
Other Identifiers
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2789/19
Identifier Type: -
Identifier Source: org_study_id
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