Non-Identical Blood Type Transfusions for Patient Outcomes
(UD Trial)
Recruiting in Palo Alto (17 mi)
Overseen byDonald Arnold
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: McMaster University
Disqualifiers: Blood group O, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing whether giving patients blood that exactly matches their own type can reduce complications and deaths. It focuses on patients who need transfusions and are at higher risk of problems when given non-matching blood. The goal is to prevent harmful immune reactions by using matching blood types.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Non-Identical Blood Type Transfusions for Patient Outcomes?
Research shows that red blood cell (RBC) transfusion therapy has been effective in reducing mortality and morbidity in patients with cancer who receive multiple transfusions. This suggests that RBC transfusions, even with non-identical blood types, could potentially improve patient outcomes.
12345Is it safe to receive a blood transfusion with a non-identical blood type?
Blood transfusions, including those with red blood cells, can have risks such as adverse reactions and complications. Studies have shown that factors like storage duration and irradiation can increase these risks, and transfusions can lead to serious reactions like hemolysis (destruction of red blood cells). While transfusions are common, they are associated with various adverse effects, especially in specific populations like newborns and patients with heart conditions.
678910How is the treatment of non-identical blood type transfusions unique compared to other treatments?
Non-identical blood type transfusions are unique because they involve transfusing blood that doesn't match the recipient's blood type exactly, which is not standard practice. This approach may focus on matching other blood components or antigens to improve outcomes, unlike traditional transfusions that prioritize exact blood type matching.
14111213Eligibility Criteria
This trial is for adults over 18 with Myelodysplastic Syndrome (MDS) who don't have leukemia. They must need regular blood transfusions every 6 weeks or less, be stable according to their doctor's assessment, and not require special blood products due to reactions. People with blood group O or those unable to consent are excluded.Inclusion Criteria
I have been diagnosed with MDS without leukemia, classified as low or intermediate-1 risk.
Blood group A, B, or AB
I am 18 years old or older.
+3 more
Exclusion Criteria
I am unable to understand and give consent for treatment.
My blood type is O.
I need special blood products due to reactions.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Transfusion Episode 1
Participants receive an ABO identical product during the first transfusion episode
1 day
1 visit (in-person)
Transfusion Episode 2
Participants receive an ABO non-identical product during the second transfusion episode
1 day
1 visit (in-person)
Follow-up
Participants are monitored for changes in biomarkers of inflammation and other safety parameters after transfusion
12-24 hours
Participant Groups
The study is examining if receiving Red Blood Cell (RBC) transfusions that aren't a perfect match for the patient's ABO blood type affects their health outcomes. It follows earlier research suggesting non-identical RBCs might increase in-hospital death risk.
2Treatment groups
Experimental Treatment
Active Control
Group I: ABO non-identical transfusionExperimental Treatment1 Intervention
All study patients will participate in the study for two consecutive transfusion episodes (a transfusion episode is defined as a clinic visit where 2 RBC units are transfused) and will receive an ABO identical product at one transfusion episode and an ABO non-identical product for the other episode. Randomization will dictate the order of the transfusion. The number of RBCs given for each study transfusion episode will be identical 2 RBC units.
Group II: ABO identical transfusionActive Control1 Intervention
All study patients will participate in the study for two consecutive transfusion episodes (a transfusion episode is defined as a clinic visit where 2 RBC units are transfused) and will receive an ABO identical product at one transfusion episode and an ABO non-identical product for the other episode. Randomization will dictate the order of the transfusion. The number of RBCs given for each study transfusion episode will be identical 2 RBC units.
RBC transfusion is already approved in European Union, United States, Canada for the following indications:
πͺπΊ Approved in European Union as Red Blood Cell transfusion for:
- Anemia
- Blood loss
- Surgical procedures
πΊπΈ Approved in United States as RBC transfusion for:
- Anemia
- Blood loss
- Surgical procedures
- Trauma
π¨π¦ Approved in Canada as Red Blood Cell transfusion for:
- Anemia
- Blood loss
- Surgical procedures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Juravinski Hospital and Cancer CentreHamilton, Canada
Loading ...
Who Is Running the Clinical Trial?
McMaster UniversityLead Sponsor
CBSCollaborator
References
RBC Transfusion Strategy in Oncological Patients with Chronic RBC Transfusion Therapy. [2023]Red blood cell (RBC) transfusion therapy has greatly reduced mortality and morbidity in multiply transfused patients with oncological malignancies. The aim of this study was to underline the necessity of introducing a policy for extended RBC phenotyping of these patients and for the issuing of antigen-matched blood (at least for E antigen).
Worldwide audit of blood transfusion practice in critically ill patients. [2018]The aim was to describe transfusion practice in critically ill patients at an international level and evaluate the effects of red blood cell (RBC) transfusion on outcomes in these patients.
No Significant Association Between the Transfusion of Small Volumes of Leukocyte-Depleted Red Blood Cells and Mortality Over 7 Years of Follow-up in Patients Undergoing Cardiac Surgery: A Propensity Score Matched Analysis. [2019]The impact of red blood cell (RBC) transfusion on long-term clinical outcome is controversial.
Predicting red blood cell transfusion in hospitalized patients: role of hemoglobin level, comorbidities, and illness severity. [2021]Randomized controlled trial evidence supports a restrictive strategy of red blood cell (RBC) transfusion, but significant variation in clinical transfusion practice persists. Patient characteristics other than hemoglobin levels may influence the decision to transfuse RBCs and explain some of this variation. Our objective was to evaluate the role of patient comorbidities and severity of illness in predicting inpatient red blood cell transfusion events.
Storage time of transfused red blood cells and impact on clinical outcomes in hematopoietic stem cell transplantation. [2011]Red blood cell (RBC) transfusion may prolong recovery in some patients, perhaps due to changes that occur during more prolonged RBC storage. We examined the impact of RBC transfusion and the age of transfused RBC units on clinical outcomes in hematopoietic stem cell transplantation (HSCT).
In vitro lysis and acute transfusion reactions with hemolysis caused by inappropriate storage of canine red blood cell products. [2021]Transfusion of red blood cell (RBC) products carries considerable risk for adverse reactions, including life-threatening hemolytic reactions.
Induction of platelet white blood cell (WBC) aggregate formation by platelets and WBCs in red blood cell units. [2008]Transfusion of red blood cell (RBC) preparations is independently associated with adverse clinical outcomes in patients with acute cardiovascular disease. This study was designed to define mechanisms potentially contributing.
Irradiation and prolonged storage of red cells are associated with increased adverse events. [2019]Red blood cell (RBC) transfusion is associated with the most transfusion-related adverse events (AE). Recent clinical studies showed no significant difference in transfusion-associated mortality between fresh and older RBCs. However, the impact of storage duration as well as irradiation on nonfatal yet much more common complications has not been fully investigated.
Adverse effects of small-volume red blood cell transfusions in the neonatal population. [2021]Adverse transfusion reactions in the neonatal population are poorly understood and defined. The incidence and pattern of adverse effects due to red blood cell (RBC) transfusion are not well known, and there has been no systematic review of published adverse events. RBC transfusions continue to be linked to the development of morbidities unique to neonates, including chronic lung disease, retinopathy of prematurity, intraventricular haemorrhage and necrotising enterocolitis. Uncertainties about the exact nature of risks alongside benefits of RBC transfusion may contribute to evidence of widespread variation in neonatal RBC transfusion practice.Our review aims to describe clinical adverse effects attributed to small-volume (10-20 mL/kg) RBC transfusions and, where possible, their incidence rates in the neonatal population through the systematic identification of all relevant studies.
Adverse Outcomes of Perioperative Red Blood Cell Transfusions in Coronary Artery Bypass Grafting in Hospital Universiti Sains Malaysia. [2023]Perioperative red blood cell (RBC) transfusion in coronary artery bypass grafting (CABG) has both benefits and harms. Our aim was to study the association between perioperative RBC transfusion and its adverse outcomes.
Signs and symptoms associated with the transfusion of WBC-reduced RBCs and non-WBC-reduced RBCs in patients with anemia and HIV infection: results from the Viral Activation Transfusion Study. [2019]RBC transfusion is associated with fever and other reactions in some patients. The Viral Activation Transfusion Study randomly assigned patients to receive either unmodified or WBC-reduced RBCs and thus offered an opportunity to assess the effect of WBC-reduced RBCs on the incidence of transfusion reactions prospectively.
Red blood cell alloimmunization in sickle cell disease and in thalassaemia: current status, future perspectives and potential role of molecular typing. [2022]Red blood cell (RBC) transfusions are a milestone in the treatment for sickle cell anaemia (SSA) and for thalassaemia. RBC alloimmunization remains a major challenge of chronic transfusion therapy, and it can lead to adverse life-threatening events. The alloimmunization risk could depend on multiple factors such as the number of transfusions and, most of all, the genetic background. Different ethnic groups are predisposed to immunization because of a significant degree of RBC antigenic mismatch between donor and recipient. There is no universal agreement and standards for the most appropriate selection of RBC units in chronically transfused subjects. Current practice only deals with compatibility of ABO, Rh and K antigens. Molecular RBC antigenic matching extended to other blood group systems is an innovative strategy to ensure a better quality and effectiveness of transfusion therapy.
Single versus double-unit transfusion: Safety and efficacy for patients with hematologic malignancies. [2020]Although hemoglobin thresholds for red blood cell (RBC) transfusion have decreased, double-unit RBC transfusion practices persist. We studied the effects switching from predominantly double-unit to single-unit RBC transfusions had on utilization and clinical outcomes for malignant hematology patients.