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NCT Number: NCT02140216

Immunomodulation Effect of Blood Transfusion

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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 Additionally withdrawn samples currently not used for analysis will stored for further studies.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No blood transfusion

Biological

No blood transfusion

Day 0 blood transfusion

Biological

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

Day 1 or 2 blood transfusion

Biological

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

Primary outcomes

  1. Macrophage inflammatory protein 1 alpha (MIP-1a)

    Time frame: 5 days

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

  2. macrophage inflammatoryprotein 1 beta (MIP-1b)

    Time frame: 5 days

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

  3. platelet-derived growth factor-BB

    Time frame: 5 days

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

  4. RANTES

    Time frame: 5 days

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

  5. tumour TNF alpha

    Time frame: 5 days

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

  6. VEGF

    Time frame: 5 days

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

  7. Ferritin

    Time frame: 5 days

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

  8. Fibrinogen

    Time frame: 5 days

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

  9. procalcitonin

    Time frame: 5 days

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

  10. interleukin

    Time frame: 5 days

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

  11. basic fibroblast growth factor (B-FGF)

    Time frame: 5 days

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

  12. eotaxin (monocyte chemotactic proteins)

    Time frame: 5 days

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

  13. G-CSF

    Time frame: 5 days

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

  14. GM-CSF

    Time frame: 5 days

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

  15. IFN-alpha

    Time frame: 5 days

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

  16. IP-10

    Time frame: 5 days

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

  17. MCP-1

    Time frame: 5 days

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

  18. MCAF

    Time frame: 5 days

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

  19. serum amyloid A

    Time frame: 5 days

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

  20. tissue plasminogen activator

    Time frame: 5 days

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

  21. Postoperative non-surgical complications

    Time frame: 30 days

    Infection, thrombosis, pulmonary affection

Secondary outcomes

  1. CD2 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  2. CD3 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  3. CD4 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  4. CD 8 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

    preoperative, postoperative day 1, 3, 5

  5. CD 8 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  6. CD 25 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  7. CD 30 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  8. CD 19 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  9. CD 20 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  10. CD 138 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  11. CD 56 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  12. CD 303 Cellular immunologic parameter (non-radioisotope),

    Time frame: 5 days

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

  13. CLT cytotoxicity (non-radioisotope),

    Time frame: 5 days

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

  14. CD 304

    Time frame: 5 days

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

  15. NK cytotoxicity

    Time frame: 5 days

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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Wolf Schleinzer Stiftung zur Wissenschafts- und Bildungsförderung, Germany

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 16, 2014
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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