Immunomodulation Following Transfusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 4
- 主要终点
- Number of Participants With Changes in the Production of Antibody to HLA Antigens
研究概览
简要总结
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.
详细描述
Blood transfusions may have opposite immune effects on patients. One is sensitization. The other is immunosuppression. The magnitude of this problem in patients who are not on chemotherapy is unknown.
Of patients who do receive donor blood, 50-90 percent become sensitized (make antibody) to HLA proteins present on white blood cells in the donor blood. This is an undesired effect in patients who need an organ or stem cell transplant, as it increases the risk of rejection. Another effect of receiving a blood transfusion, immunosuppression, causes a decreased immune response that compromises patients' ability to fight off infection or tumor cells.
These effects - sensitization and immunosuppression - are thought to be due largely to white blood cells present in the transfusion product. Doctors order specially pretreated blood transfusions that have been depleted of white blood cells with the aim of minimizing risks in an "immunocompromised" patient. "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. Therefore, blood is pretreated both ways before it is given to patients who need a stem cell transplant or others who are immunosuppressed.
Sometimes the pretreated leukofiltration and gamma-irradiated blood is used for "regular" patients who are not immunocompromised so the blood is used before it expires and not wasted. However, doctors do not know for sure whether these expensive pretreatments are really beneficial for "regular" patients such as those undergoing cardiac surgery and whether they would change the risk of developing sensitization or immunosuppression.
In this study, patients 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Clinical teams caring for patients were not masked. Laboratory personnel were masked until all testing completed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
3
Blood components leukoreduced and irradiated
干预措施: Leukoreduced and irradiated (Biological)
1
Blood components with no additional treatment
干预措施: Standard blood components (Biological)
2
Blood components leukoreduced
干预措施: Leukoreduced blood components (Biological)
结局指标
主要结局
Number of Participants With Changes in the Production of Antibody to HLA Antigens
时间窗: 0 to 5 weeks after surgery
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.
次要结局
- 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(0 to 5 weeks after surgery)
研究者
Karen Nelson
Director
University of Washington