Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT04859218

Conditions

Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RBC transfusion

Study Details

Brief summary:

In a recent analysis of a large transfusion database (Transfusion Research Utilization, Surveillance and Tracking database \[TRUST\]), the investigators found that the transfusion of ABO non-identical RBCs to group A individual was associated with an increased risk of death in-hospital compared to patients transfused with ABO identical RBCs (Red Blood Cells). Our finding was corroborated in a separate study of low birth weight neonates who received only group O RBCs (e.g., group O neonates received ABO identical RBCs but group A, B, and AB neonates received ABO non-identical RBCs). A subgroup of neonates who received ABO non-identical transfusions had higher mortality (Z. Sohl, personal communication, April 30th, 2020). Similar adverse clinical outcomes have been reported in a number of studies where patients have received ABO non-identical RBCs and/or platelets. Together, these findings raise the concern that the longstanding policy of transfusing group O non-identical RBCs and platelets may increase the risk of harm for some patients. In Hamilton, Ontario hospitals, approximately 20% of transfused patients receive ABO non-identical RBCs every year because of inventory shortages, urgent requests, and specific phenotype requirements. The negative impact of this practice could have widespread national and international implications for transfusion policy.

The ability to undertake critical exploratory analyses in transfusion medicine is enabled by large research and administrative data sets that include all Hamilton hospitals. The initial finding of potential harm with ABO non-identical RBCs is hypothesis-generating and requires confirmation through external datasets and translational studies to support a biological mechanism. If confirmed, this hypothesis can then be tested in a clinical trial.

Conditions

Myelodysplastic Syndrome

Study ID

NCT04859218

Start date

Oct 17, 2023

Status verified date

Oct, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years of age
2. Diagnosis of MDS (Myelodysplastic syndrome ) without leukemia (IPSS-R classified or physician indicated either low-risk or intermediate-1)
3. Stable disease (as assessed by the patient's physician using MDS Stability Assessment Algorithm)
4. Blood group A, B, or AB
5. Requiring 2 RBC units at least every 6 weeks or less
6. Receiving transfusions in an outpatient setting

Exclusion Criteria:

1. Unable to provide informed consent
2. Blood group O
3. Clinical requirement for special products because of reactions (e.g. washed or volume-reduced)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABO non-identical transfusion

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.

active comparator: ABO identical transfusion

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.

Interventions

RBC transfusion

two consecutive transfusion episodes: an ABO identical product at one transfusion episode and an ABO non-identical product for the other episode. The number of RBCs given for each study transfusion episode will be identical 2 RBC units.

Primary outcome measure

  • Change in the biomarkers of inflammation(C-Reactive Protein, Circulating Immune Complexes, IL-6, IL-1β, TNF-α, IL-8, CD40 Ligand) [ Time Frame: Baseline ]
  • Change in the biomarkers of inflammation from baseline (C-Reactive Protein, Circulating Immune Complexes, IL-6, IL-1β, TNF-α, IL-8, CD40 Ligand) [ Time Frame: 1 hour after transfusion ]
  • Change in the biomarkers of inflammation from baseline (C-Reactive Protein, Circulating Immune Complexes, IL-6, IL-1β, TNF-α, IL-8, CD40 Ligand) [ Time Frame: 12-24 hours after transfusion ]

Central Contacts and Locations

Locations

Juravinski Hospital and Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V-1C3

Contacts

More Information

Sponsor

McMaster University

Last update posted

Oct 17, 2024

Last verified

Oct, 2024

Keywords

  • MDS
  • myeloid clonal disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-10-17.