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Blood Product
Non-Identical Blood Type Transfusions for Patient Outcomes (UD Trial)
N/A
Recruiting
Led By Donald Arnold
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of MDS (Myelodysplastic syndrome ) without leukemia (IPSS-R classified or physician indicated either low-risk or intermediate-1)
Age ≥ 18 years of age
Must not have
Unable to provide informed consent
Blood group O
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour after transfusion
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not detailed here, generally, risks from mismatched RBC transfusions can include allergic reactions, fever, iron overload, and rarely hemolytic transfusion reactions where the body attacks the new cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with MDS without leukemia, classified as low or intermediate-1 risk.
Select...
I am 18 years old or older.
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I need blood transfusions of 2 units at least every 6 weeks.
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I am getting blood transfusions outside the hospital.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand and give consent for treatment.
Select...
My blood type is O.
Select...
I need special blood products due to reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the biomarkers of inflammation from baseline (C-Reactive Protein, Circulating Immune Complexes, IL-6, IL-1β, TNF-α, IL-8, CD40 Ligand)
Change in the biomarkers of inflammation(C-Reactive Protein, Circulating Immune Complexes, IL-6, IL-1β, TNF-α, IL-8, CD40 Ligand)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RBC transfusion
2013
Completed Phase 3
~290
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Myelodysplastic Syndrome (MDS) include erythropoiesis-stimulating agents (ESAs), thrombopoietin mimetics, and DNA methyltransferase inhibitors. ESAs, such as epoetin alfa, stimulate red blood cell production to alleviate anemia and reduce the need for transfusions.
Thrombopoietin mimetics, like romiplostim, aim to increase platelet counts but are used cautiously due to potential risks of leukemic transformation. DNA methyltransferase inhibitors, such as azacitidine and decitabine, work by reversing abnormal DNA methylation patterns, thereby restoring normal gene function and inhibiting cancer cell growth.
Ensuring compatibility in treatments, similar to the ABO Identical RBC Transfusion trial, is crucial to minimize immune-mediated adverse effects and improve patient outcomes.
Therapeutic modalities for patients with lower-risk myelodysplastic syndromes: current options and future directions.Combination therapy with DNA methyltransferase inhibitors in hematologic malignancies.
Therapeutic modalities for patients with lower-risk myelodysplastic syndromes: current options and future directions.Combination therapy with DNA methyltransferase inhibitors in hematologic malignancies.
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Who is running the clinical trial?
CBSUNKNOWN
1 Previous Clinical Trials
250 Total Patients Enrolled
McMaster UniversityLead Sponsor
916 Previous Clinical Trials
2,615,229 Total Patients Enrolled
Donald ArnoldPrincipal InvestigatorMcMaster University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and give consent for treatment.I have been diagnosed with MDS without leukemia, classified as low or intermediate-1 risk.I am 18 years old or older.My blood type is O.I need special blood products due to reactions.I need blood transfusions of 2 units at least every 6 weeks.I am getting blood transfusions outside the hospital.
Research Study Groups:
This trial has the following groups:- Group 1: ABO non-identical transfusion
- Group 2: ABO identical transfusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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