The Immunomodulation Effect of Blood Transfusion in Operative Spine Surgery Patients

NCT ID: NCT02069210

Last Updated: 2014-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infection After Transfusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood transfusion

Patients receive blood transfusion during operation

Blood transfusion

Intervention Type OTHER

Intraoperative blood transfusion

Interventions

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Blood transfusion

Intraoperative blood transfusion

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolf-Schleinzer-Stiftung

UNKNOWN

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Sirilak Suksompong

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sirilak Suksompong, MD

Role: STUDY_DIRECTOR

Department of Anesthesiology, Faculty of medicine Siriraj Hospital, Mahidol University

Locations

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Sirilak Suksompong

Bangkok, , Thailand

Site Status

Countries

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Thailand

Central Contacts

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Sirilak Suksompong, MD

Role: CONTACT

66891534806

Facility Contacts

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Sirilak Suksompong, MD

Role: primary

66891534806

Other Identifiers

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SI 1

Identifier Type: -

Identifier Source: org_study_id

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