An observational study in Incompatible Blood Transfusion, Immune Defect and Surgery, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-08.
Sponsored by Mahidol University · Observational
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.
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 Additionally withdrawn samples currently not used for analysis will stored for further studies.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.
Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing elective spine surgery/
Exclusion Criteria:
Patients undergoing elective spine surgery receiving intra- or immediate-postoperative red cell blood transfusion.
Biological: Day 0 blood transfusion
Patients undergoing elective spine surgery receiving first red cell blood transfusion on day 1 or 2 after surgery.
Biological: Day 1 or 2 blood transfusion
Patients undergoing elective spine surgery receiving no blood transfusion.
Biological: No blood transfusion
No blood transfusion
Patients undergoing elective spine surgery receiving intra- or immediate-postoperative red cell blood transfusion.
Patients undergoing elective spine surgery receiving first red cell blood transfusion on day 1 or 2 after surgery.
Macrophage inflammatory protein 1 alpha (MIP-1a)
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
macrophage inflammatoryprotein 1 beta (MIP-1b)
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
platelet-derived growth factor-BB
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
RANTES
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
tumour TNF alpha
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
VEGF
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
Ferritin
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
Fibrinogen
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
procalcitonin
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
interleukin
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
basic fibroblast growth factor (B-FGF)
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
eotaxin (monocyte chemotactic proteins)
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
G-CSF
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
GM-CSF
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
IFN-alpha
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
IP-10
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
MCP-1
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
MCAF
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
serum amyloid A
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
tissue plasminogen activator
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
Postoperative non-surgical complications
Infection, thrombosis, pulmonary affection
Time frame: 30 days
CD2 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD3 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD4 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD 8 Cellular immunologic parameter (non-radioisotope),
preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD 8 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD 25 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD 30 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD 19 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD 20 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD 138 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD 56 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD 303 Cellular immunologic parameter (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CLT cytotoxicity (non-radioisotope),
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
CD 304
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
NK cytotoxicity
Blood sample on preoperative, postoperative day 1, 3, 5
Time frame: 5 days
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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