The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

Infection After Transfusion Clinical Trial

Official title:

The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02069210
• Other study ID #: SI 1
• Status: Not yet recruiting
• Phase: N/A
• First received: February 17, 2014
• Last updated: February 19, 2014
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2014
• Source: Mahidol University
• Contact: Sirilak Suksompong, MD
• Phone: 66891534806
• Email: sirilak.suk[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the effect of transfusion of allogeneic (homologous) red cells on the immunologic parameters such as T-cells as well as natural killer cell count/function, various interleukins, TNF alpha and other immunologic relevant parameters on postoperative day 1,3 and 5-7 in patients undergoing spine surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age > 18 - < 60 years

• Patients underwent elective spine surgery

• ASA classification 1-3

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.

• Intraoperative massive bleeding

• Infection of the spine

• Rheumatoid arthritis

• Patients who had either of the following drug (aspirin, methotrexate, cyclosporine, qualaquin)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection After Transfusion

Intervention

Other:
• Blood transfusion
Intraoperative blood transfusion

Locations

Country	Name	City	State
Thailand	Sirilak Suksompong	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Wolf-Schleinzer-Stiftung

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunologic parameters	Blood level of the following parameters on preoperative, postoperative day 1, 3, 5-7.; IL-1beta, IL-1ra, IL-2, IL-4, IL-5, IL-6, Il-7, IL-8, Il-9, Il-10, Il-12, Il-13, IL-15, Il-17,basic FGF (Fibroblast growth factors).; Cell Analytics - (mononuclear) T-Cells incl. killer cells, CD2, CD3, CD4, CD8, CD25, CD30, CD19, CD20, CD138, CD56, CD56, CD303, CD304, NK cytotoxicity (non-radioisotope), CTL cytotoxicity (non-radioisotope), T cell proliferation, B cell, T cell.	7 days	Yes
Secondary	To determine the effect of red cell transfusion on clinical relevant outcome parameters, such as myocardial infarction, infection rate, and length of hospital stay.		1 month	Yes