Stored RBC Transfusion and Immonomodulation

NCT ID: NCT01976234

Last Updated: 2016-02-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-12-31

Brief Summary

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Transfusion of RBC is associated with post operative infections. Our hypothesis is that stored blood could be related with increased post operative infection risk. Surgical patients transfused during the operation or immediately after will be included in our study. Patients will receive fresh or old blood during the whole recovery.

Detailed Description

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Conditions

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Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fresh group

Fresh group will receive RBC stored for less than 14 days

Group Type ACTIVE_COMPARATOR

Fresh RBC

Intervention Type OTHER

Patients will receive fresh blood only

Old group

Old group will receive RBC stored for 14 days or more

Group Type ACTIVE_COMPARATOR

Old RBC

Intervention Type OTHER

Interventions

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Fresh RBC

Patients will receive fresh blood only

Intervention Type OTHER

Old RBC

Intervention Type OTHER

Other Intervention Names

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Patients will receive blood stored for 14 days or more

Eligibility Criteria

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Inclusion Criteria

* Patients transfused during or in 24h after surgical operation

Exclusion Criteria

* Patients transfused during the 30 days before the operation
* Immunodepressed patients
* Infections during the 30 days before operations
* Emergency surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Savino Spadaro

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Savino Spadaro

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Locations

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Sant'Anna Hospital

Ferrara, Ferrara, Italy

Site Status

Countries

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Italy

References

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Juffermans NP, Vlaar AP, Prins DJ, Goslings JC, Binnekade JM. The age of red blood cells is associated with bacterial infections in critically ill trauma patients. Blood Transfus. 2012 Jul;10(3):290-5. doi: 10.2450/2012.0068-11. Epub 2012 Feb 22.

Reference Type RESULT
PMID: 22395349 (View on PubMed)

Other Identifiers

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04121985

Identifier Type: -

Identifier Source: org_study_id

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