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Immunomodulation Effect of Blood Transfusion

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02140216
Enrollment
60
Registered
2014-05-16
Start date
2014-05-31
Completion date
2018-04-10
Last updated
2021-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Defect, Incompatible Blood Transfusion, Surgery

Keywords

Blood transfusion, Immune, Surgery

Brief summary

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.

Detailed description

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 Additionally withdrawn samples currently not used for analysis will stored for further studies.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.

Interventions

No blood transfusion

BIOLOGICALDay 0 blood transfusion

Patients undergoing elective spine surgery receiving intra- or immediate-postoperative red cell blood transfusion.

BIOLOGICALDay 1 or 2 blood transfusion

Patients undergoing elective spine surgery receiving first red cell blood transfusion on day 1 or 2 after surgery.

Sponsors

Wolf Schleinzer Stiftung zur Wissenschafts- und Bildungsförderung, Germany
CollaboratorUNKNOWN
Mahidol University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative non-surgical complications30 daysInfection, thrombosis, pulmonary affection
Ferritin5 daysBlood sample on preoperative, postoperative day 1, 3, 5
Fibrinogen5 daysBlood sample on preoperative, postoperative day 1, 3, 5
procalcitonin5 daysBlood sample on preoperative, postoperative day 1, 3, 5
interleukin5 daysBlood sample on preoperative, postoperative day 1, 3, 5
basic fibroblast growth factor (B-FGF)5 daysBlood sample on preoperative, postoperative day 1, 3, 5
eotaxin (monocyte chemotactic proteins)5 daysBlood sample on preoperative, postoperative day 1, 3, 5
G-CSF5 daysBlood sample on preoperative, postoperative day 1, 3, 5
GM-CSF5 daysBlood sample on preoperative, postoperative day 1, 3, 5
IFN-alpha5 daysBlood sample on preoperative, postoperative day 1, 3, 5
IP-105 daysBlood sample on preoperative, postoperative day 1, 3, 5
MCP-15 daysBlood sample on preoperative, postoperative day 1, 3, 5
MCAF5 daysBlood sample on preoperative, postoperative day 1, 3, 5
serum amyloid A5 daysBlood sample on preoperative, postoperative day 1, 3, 5
tissue plasminogen activator5 daysBlood sample on preoperative, postoperative day 1, 3, 5
Macrophage inflammatory protein 1 alpha (MIP-1a)5 daysBlood sample on preoperative, postoperative day 1, 3, 5
macrophage inflammatoryprotein 1 beta (MIP-1b)5 daysBlood sample on preoperative, postoperative day 1, 3, 5
platelet-derived growth factor-BB5 daysBlood sample on preoperative, postoperative day 1, 3, 5
RANTES5 daysBlood sample on preoperative, postoperative day 1, 3, 5
tumour TNF alpha5 daysBlood sample on preoperative, postoperative day 1, 3, 5
VEGF5 daysBlood sample on preoperative, postoperative day 1, 3, 5

Secondary

MeasureTime frameDescription
CD3 Cellular immunologic parameter (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CD4 Cellular immunologic parameter (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CD 8 Cellular immunologic parameter (non-radioisotope),5 dayspreoperative, postoperative day 1, 3, 5
CD 25 Cellular immunologic parameter (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CD 30 Cellular immunologic parameter (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CD 19 Cellular immunologic parameter (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CD 20 Cellular immunologic parameter (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CD 138 Cellular immunologic parameter (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CD 56 Cellular immunologic parameter (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CD 303 Cellular immunologic parameter (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CLT cytotoxicity (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CD 3045 daysBlood sample on preoperative, postoperative day 1, 3, 5
NK cytotoxicity5 daysBlood sample on preoperative, postoperative day 1, 3, 5
CD2 Cellular immunologic parameter (non-radioisotope),5 daysBlood sample on preoperative, postoperative day 1, 3, 5

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026