TransfusionNCT04859855
Transfusional Trigger in Post-operative Oncologic Patients in Critical Care
A study testing Restrictive transfusional strategy and Liberal transfusional strategy in people with Transfusion and Oncology, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfusion, Oncology, Critical Care
- What is being tested?
- Restrictive transfusional strategy and Liberal transfusional strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteBrazil
- Study dates
- May 2021to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
ACCamargoCC
São Paulo, São Paulo, 01509900
Raissa Molla, 11984359482, raissa.gomes@accamargo.org.br
About this study
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.
Read the detailed 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.
- Conditions
- Transfusion, Oncology, Critical Care, Surgery
- Being tested
- Restrictive transfusional strategy, Liberal transfusional strategy
- Keywords
- transfusion, trigger, oncology, post operative, critical care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive transfusional strategyProcedure or surgery
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 transfusional strategyProcedure or surgery
Transfusion of RBC if Hb ≤9,0g/dL, with the aim of maintaining Hb levels between 9,0-10,0g/dL
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Liberal transfusional strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mortality
Mortality 30 days post-randomization
Measured: 30 days
Secondary outcomes (13)
Rate of mortality at 60 and 90 days post-randomization
Mortality at 60 and 90 days post-randomization
Measured: 60 and 90 days
Rate of mortality in hospital and ICU admission
Mortality in hospital and ICU admission
Measured: 90 days after randomization
Number of days alive
Days alive during the 90 days after randomization
Measured: 90 days after randomization
Duration of ICU and hospital stay
Duration of ICU and hospital stay
Measured: 90 days after randomization
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
Measured: 90 days after randomization
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
Measured: 90 days after randomization
Number of days alive without mechanical ventilation
Days alive without mechanical ventilation 90 days after randomization
Measured: 90 days after randomization
Number of days alive without vasopressor/inotropic therapy
Days alive without vasopressor/inotropic therapy 90 days after randomization
Measured: 90 days after randomization
Number of days alive without dialysis/hemofiltration 90 days after randomization
Days alive without dialysis/hemofiltration
Measured: 90 days after randomization
Rate of acute ischemic events occurring in the ICU
Total frequency of events: stroke, myocardial infarction, unstable angina, mesenteric ischemia, peripheral ischemia
Measured: 90 days after randomization
Total frequency of verified infections during ICU admission
Total frequency of verified infections during ICU admission
Measured: 90 days after randomization
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)
Measured: 90 days after randomization
Rate of reoperation
Not previously programmed
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina P Colella, MD PhD, Principal investigator, ACCamargo Cancer Center/ State University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859855
- Sponsor's protocol ID
- 2789/19
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8874456Carson 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.
PubMed 12375651Carson 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.
PubMed 27731885Carson 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.
PubMed 22168590de 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.
PubMed 25401417Holst 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.
PubMed 25270275Hovaguimian 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.
PubMed 27167445Hebert 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.
PubMed 9971864Hebert 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.
PubMed 11246298American 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.
PubMed 25545654Shander 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.
PubMed 24527739Taira 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.
PubMed 23033944Vieira 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.
PubMed 28589643Wang 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.
PubMed 19682346Weiskopf 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.
PubMed 12559019
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusional Trigger in Post-operative Oncologic Patients in Critical Care
- ClinicalTrials.gov ID
- NCT04859855
- Acronym / sponsor ID
- 2789/19
- Conditions
- Transfusion, Oncology, Critical Care, Surgery
- Keywords
- transfusion, trigger, oncology, post operative, critical care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Restrictive strategy (arm A) | Experimental | Procedure: Restrictive transfusional strategyTransfusion of RBC if Hb ≤7,0g/dL with the aim of maintaining Hb levels between 7,0-9,0g/dL. |
| Liberal strategy (arm B) | Experimental | Procedure: Liberal transfusional strategyTransfusion of RBC if Hb ≤9,0g/dL, with the aim of maintaining Hb levels between 9,0-10,0g/dL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrictive transfusional strategyTransfusion of Red Blood Concentrates (RBCs) if Hb ≤7,0g/dL with the aim of maintaining Hb levels between 7,0-9,0g/dL. | Procedure or surgery | Restrictive strategy (arm A) |
| Liberal transfusional strategyTransfusion of RBC if Hb ≤9,0g/dL, with the aim of maintaining Hb levels between 9,0-10,0g/dL | Procedure or surgery | Liberal strategy (arm B) |
Primary outcome
Rate of mortality
Time frame: 30 days
Mortality 30 days post-randomization
13 secondary outcomes
Rate of mortality at 60 and 90 days post-randomization
Time frame: 60 and 90 days
Rate of mortality in hospital and ICU admission
Time frame: 90 days after randomization
Number of days alive
Time frame: 90 days after randomization
Duration of ICU and hospital stay
Time frame: 90 days after randomization
Number of days alive and out of the hospital during the 90 days after randomization
Time frame: 90 days after randomization
Rate of organ dysfunction
Time frame: 90 days after randomization
Number of days alive without mechanical ventilation
Time frame: 90 days after randomization
Number of days alive without vasopressor/inotropic therapy
Time frame: 90 days after randomization
Number of days alive without dialysis/hemofiltration 90 days after randomization
Time frame: 90 days after randomization
Rate of acute ischemic events occurring in the ICU
Time frame: 90 days after randomization
Total frequency of verified infections during ICU admission
Time frame: 90 days after randomization
Rate of severe adverse transfusional reactions
Time frame: 90 days after randomization
Rate of reoperation
Time frame: 90 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Background: PubMed 8874456Carson 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.
- Background: PubMed 12375651Carson 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.
- Background: PubMed 27731885Carson 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.
- Background: PubMed 22168590Carson 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.
- Background: PubMed 25401417de 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.
- Background: PubMed 25270275Holst 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.
- Background: PubMed 27167445Hovaguimian 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.
- Background: PubMed 9971864Hebert 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.
- Background: PubMed 11246298Hebert 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.
- Background: PubMed 25545654American 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.
- Background: PubMed 24527739Shander 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.
- Background: PubMed 23033944Taira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina P Colella, MD PhD principal investigator
ACCamargo Cancer Center/ State University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrictive transfusional strategy and Liberal transfusional strategy in people with Transfusion and Oncology, run by AC Camargo Cancer Center at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raissa PG de Molla, MD (+5511984359482, raissa.gomes@accamargo.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859855, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.