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临床试验/NCT02140216
NCT02140216已完成不适用

Allogeneic Red Cell Transfusion and Its Influence on Relevant Humoral and Cellular Immunological Parameters

Mahidol University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
tissue plasminogen activator

研究概览

简要总结

An increasing number of publications have demonstrated that homologous (allogeneic) blood transfusion impairs outcome in cancer and non-cancer patients. Leukocyte depletion of blood products cannot solve these problems, despite improved quality of red cells; a recent study demonstrated deteriorated outcome of cancer patients with elective colon surgery and transfusion of leukocyte depleted allogeneic blood.

详细描述

All patients undergo the identical anesthesiological procedure, including premedication, general anesthesia with endotracheal intubation, monitoring and postoperative pain therapy and mobilization.Surgery is performed by the identical team performing a standardized technique.

Transfusion regimen The 'trigger' for homologous red cell transfusion intra- and postoperatively is the actual hematocrit concentration. Transfusion depends on discretion of the treating physicians. Number of units transfused, amount of blood loss, time, reasoning and decision maker are recorded.

Blood samples Within the kind of surgical procedures chosen for this study the chance of red cell transfusion is about 60 - 70%. In terms of figures 10 non-transfused cases could be gained within 40 cases in total. However, transfusion or non-transfusion does not happen in a row. We expect the total number of patients with blood withdrawal to be between 50 and 60. Additionally withdrawn samples currently not used for analysis will stored for further studies.

The purpose to include non-transfused otherwise fully comparable patients is to distinguish between trauma (operation) and transfusion and their influence on immune modulation. Within the studies about blood transfusion and immune modulation only some few made this differentiation. In patients with colorectal cancer surgery randomized groups with autologous predonation and patients with allogeneic transfusion only have been compared. However, within the latter (allogeneic) group of 27 patients only 13 had to be transfused, thus creating a non-transfusion group of 14 patients. These 14 non-transfused patients remained within the study being compared with autologous and allogeneic transfused patients. Operative trauma and allogeneic transfusion both increased the secretion of several cytokines including tumor necrosis factor (TNF) alpha and Interleukin-10; this effect was less pronounced in patients with autologous- and without any transfusion. Another group studied forty three orthopedic patients with total knee- or hip-arthroplasty, initially to compare autologous to allogeneic red cell transfusion. They had to change their protocol due to the small number of allogeneic transfusions (8 of 43). Including perioperatively transfused patients only (n = 37) they found an increase in immune regulatory cytokine Interleukin (IL)-10 after red cell transfusion, which was most pronounced 7 days after surgery, whereas there was only a mild increase in non- or autologous transfused patients. Unfortunately they did not differentiate between autologous-and non-transfused patients. Thus their data could not reveal the effect of surgery itself on the analyzed parameters.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective spine surgery
  • American Society of Anesthesiologist Risk score classification (ASA) I-III
  • Hemoglobin > 9 gm/dL

排除标准

  • Patients who have the concomitant condition; cancer, history of heart disease including, heart failure, coronary artery disease, hypertension treated with more than one medicament, serum creatinine > 1.5 mg/dL., stroke, neurologic and mental deficits, epilepsy, general or local infection (site of surgery), coagulation disorders, rheumatoid arthritis.
  • Patients who have one of the following drugs; aspirin, methotrexate, cyclosporin, qualaquin

结局指标

主要结局

tissue plasminogen activator

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

Macrophage inflammatory protein 1 alpha (MIP-1a)

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

RANTES

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

tumour TNF alpha

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

Ferritin

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

IFN-alpha

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

MCP-1

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

MCAF

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

macrophage inflammatoryprotein 1 beta (MIP-1b)

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

Fibrinogen

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

procalcitonin

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

platelet-derived growth factor-BB

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

VEGF

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

basic fibroblast growth factor (B-FGF)

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

interleukin

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

eotaxin (monocyte chemotactic proteins)

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

G-CSF

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

GM-CSF

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

serum amyloid A

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

IP-10

时间窗: 5 days

Blood sample on preoperative, postoperative day 1, 3, 5

Postoperative non-surgical complications

时间窗: 30 days

Infection, thrombosis, pulmonary affection

次要结局

  • CD2 Cellular immunologic parameter (non-radioisotope),(5 days)
  • CD3 Cellular immunologic parameter (non-radioisotope),(5 days)
  • CD 20 Cellular immunologic parameter (non-radioisotope),(5 days)
  • CLT cytotoxicity (non-radioisotope),(5 days)
  • CD 304(5 days)
  • CD 25 Cellular immunologic parameter (non-radioisotope),(5 days)
  • CD4 Cellular immunologic parameter (non-radioisotope),(5 days)
  • CD 8 Cellular immunologic parameter (non-radioisotope),(5 days)
  • CD 30 Cellular immunologic parameter (non-radioisotope),(5 days)
  • CD 19 Cellular immunologic parameter (non-radioisotope),(5 days)
  • CD 303 Cellular immunologic parameter (non-radioisotope),(5 days)
  • CD 138 Cellular immunologic parameter (non-radioisotope),(5 days)
  • CD 56 Cellular immunologic parameter (non-radioisotope),(5 days)
  • NK cytotoxicity(5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benno von Bormann

Professor

Mahidol University

研究点 (1)

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