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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-24 hours after transfusion

Awards & highlights

UD Trial Summary

This trial found that transfusions of ABO non-identical RBCs to group A individuals was associated with higher in-hospital mortality. A clinical trial is needed to confirm this hypothesis.

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.Check my eligibility

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.See study design

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.

UD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with MDS without leukemia, classified as low or intermediate-1 risk.

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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.

UD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

UD 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RBC transfusion

2013

Completed Phase 3

~290

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

CBSUNKNOWN

1 Previous Clinical Trials

250 Total Patients Enrolled

McMaster UniversityLead Sponsor

881 Previous Clinical Trials

2,597,860 Total Patients Enrolled

Donald ArnoldPrincipal InvestigatorMcMaster University

Media Library

RBC transfusion (Blood Product) Clinical Trial Eligibility Overview. Trial Name: NCT04859218 — N/A

Myelodysplastic Syndrome Research Study Groups: ABO non-identical transfusion, ABO identical transfusion

Myelodysplastic Syndrome Clinical Trial 2023: RBC transfusion Highlights & Side Effects. Trial Name: NCT04859218 — N/A

RBC transfusion (Blood Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04859218 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications must an individual possess to be eligible for participation in this clinical trial?

"Prospective participants must possess myelodysplastic syndrome and be between 18-120 years old to qualify for this clinical trial. 30 applicants will be chosen in total."

Answered by AI

Does this trial include participants younger than sixty years of age?

"According to the clinical trial's inclusion criteria, participants must fall between 18 and 120 years of age. Specifically, there are 91 trials dedicated to minors while 376 are reserved for individuals over 65."

Answered by AI

Is this investigation currently accepting participants?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial is actively recruiting participants, with its publication originally appearing on February 1st 2023 and subsequently updated on the thirteenth of the same month. The research seeks to recruit 30 patients at a single medical site."

Answered by AI

How many participants are being accepted into this clinical exploration?

"Indeed, the information hosted on clinicaltrials.gov affirms that recruitment for this medical experiment is still in progress. The trial was first posted on February 1st 2023 and has since been updated - with the last edit made on February 13th 2023. This study seeks to enrol 30 patients at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Revisiting the Universal Donor: Does Exposure to O Blood Products Affect Patient Outcomes?

2023. "Revisiting the Universal Donor: Does Exposure to O Blood Products Affect Patient Outcomes?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04859218.