The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

• Sponsor: Mahidol University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02069210
• Collaborator: Wolf-Schleinzer-Stiftung (Other)
• Enrollment: 40
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infection After Transfusion	Other: Blood transfusion

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients
• Study Start Date: May 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Blood transfusion Patients receive blood transfusion during operation	Other: Blood transfusion; Intraoperative blood transfusion

Outcome Measures

Primary Outcome Measures

1. Immunologic parameters [7 days]

   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.

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sirilak Suksompong	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University
• Wolf-Schleinzer-Stiftung

Investigators

• Study Director: Sirilak Suksompong, MD, Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sirilak Suksompong, Associated Professor, Mahidol University
• ClinicalTrials.gov Identifier: NCT02069210
• Other Study ID Numbers: SI 1
• First Posted: Feb 24, 2014
• Last Update Posted: Feb 24, 2014
• Last Verified: Feb 1, 2014

Study Results

No Results Posted as of Feb 24, 2014