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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 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 287 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00810810
The ClinicalTrials.gov registry entry for NCT00810810 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 287 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Standard blood components is the first listed.
NCT00810810 reports 0 study locations.
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.
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