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NCT00810810 · ClinicalTrials.gov registry record · Phase 4
Immunomodulation Following Transfusion
A Phase 4 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 287
- Enrollment target
NCT00810810: Completed Phase 4 study, sponsored by University of Washington.
NCT00810810 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 287 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00810810, a Phase 4 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 287 participants
- Enrollment target
Study 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.
Primary Outcome
Blood samples were collected prior to surgery and at two times after surgery. Serum was tested for the presence of IgG antibody to HLA. the results of the samples collected after surgery were compared to those in the sample collected prior to surgery.
Interventions
- BIOLOGICAL Standard blood components
- BIOLOGICAL Leukoreduced blood components
- BIOLOGICAL Leukoreduced and irradiated
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 287 participants |
| Start Date | 2006-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 4 |
What the finished NCT00810810 record still lists
NCT00810810 is an interventional study that assigns participants to a tested intervention. The registered 287 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard blood components is the first listed.
NCT00810810 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00810810 about?
NCT00810810 is a clinical study titled "Immunomodulation Following Transfusion". 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 chemotherap...
What is the current status of trial NCT00810810?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 287 participants. The study started on 2006-07. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00810810?
The interventions under investigation include: Standard blood components (BIOLOGICAL), Leukoreduced blood components (BIOLOGICAL), Leukoreduced and irradiated (BIOLOGICAL).
Who is sponsoring clinical trial NCT00810810?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00810810's enrollment target sits among peer trials
287 301st of 2000 higher than 1,700 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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