NCT01976234

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 5, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

September 30, 2013

Last Update Submit

February 2, 2016

Conditions

Infections

Outcome Measures

Primary Outcomes (1)

  • Incidence of infections

    28 days

Study Arms (2)

Fresh group

ACTIVE COMPARATOR

Fresh group will receive RBC stored for less than 14 days

Other: Fresh RBC

Old group

ACTIVE COMPARATOR

Old group will receive RBC stored for 14 days or more

Other: Old RBC

Interventions

Fresh RBCOTHER

Patients will receive fresh blood only

Fresh group
Old RBCOTHER
Also known as: Patients will receive blood stored for 14 days or more
Old group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients transfused during or in 24h after surgical operation

You may not qualify if:

  • Patients transfused during the 30 days before the operation
  • Immunodepressed patients
  • Infections during the 30 days before operations
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sant'Anna Hospital

Ferrara, Ferrara, 44121, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22395349RESULT

MeSH Terms

Conditions

Infections

Study Officials

  • Savino Spadaro

    Università degli Studi di Ferrara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

September 30, 2013

First Posted

November 5, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

IT(1)