Phase 4
N=280
Immunomodulation Following Transfusion
Blood Component Transfusion
Bottom Line
View on ClinicalTrials.gov: NCT00810810 ↗Enrolled (actual)
280
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Number of Participants With Changes in the Production of Antibody to HLA Antigens — 2; 6; 2; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Standard blood components (Biological); Leukoreduced blood components (Biological); Leukoreduced and irradiated (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Changes in the Production of Antibody to HLA Antigens |
2; 6; 2; 5; 11; 10 | — |
| SECONDARY Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines |
30; 11; 12; 7; 37; 7 | — |
Summary
This study is designed to provide information on patients' immune response after exposure to transfused blood.
Blood transfusions may have opposite immune effects on patients. One is sensitization. The other is immunosuppression. The magnitude of these effects in patients who are not on chemotherapy is unknown.
These effects are thought to be due largely to white blood cells present in the transfusion product. "Leukofiltration" and "gamma-irradiation" are the special treatments that deplete white blood cells. A combination of leukofiltration and gamma-irradiation pretreatment of donor blood is thought to deplete the white blood cells most effectively.
In this study, patients scheduled for cardiac surgery are randomly assigned to receive blood products pretreated in one of three ways: untreated, filtered or filtered and irradiated. If their physician orders transfusions, they will receive products assigned to their group. Patients are asked to provide two blood samples during the 4 weeks after surgery.
Studies will measure changes in antibody to HLA and in cells that regulate the immune response. The levels of sensitization and immunosuppression will be correlated to the transfusion products received.
Eligibility Criteria
Inclusion Criteria
- At least 18 year of age
- Scheduled for open heart surgery of cardiopulmonary bypass that involves: CABG, CABG with valve, aneurysm repair
- Urgent or elective surgery
Exclusion Criteria
- Scheduled for open heart surgery of cardiopulmonary bypass that involves: placement of a ventricular assist device, cardiac transplantation, aortic dissection repair
- Emergent surgery
- participation in other clinical research studies within 30 days of randomization.
- Immunosuppressive treatment.
- Refuse blood transfusion
- Disease or condition placing subject at undue risk or decision of attending doctor.
- Condition requiring high volume transfusion therapy
Data sourced from ClinicalTrials.gov (NCT00810810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.