Effects on Septic Patient's Microcirculation of the Transfusion of Different Types of Concentrated RBCs.

NCT ID: NCT01584999

Last Updated: 2012-05-23

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

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Brief Summary

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Aim of the study is to evaluate the effects, on microcirculation of septic patient, of three types of RBCs: 1- fresh standard RBCs (storage \<10 days); 2-leukodepleted RBCs and 3-old standard RBCs (storage \>15 days) respectively. Before and 1 hour after the transfusion, microcirculation is evaluated using Sidestream Dark Field Imaging (SDF) and Near InfraRed Spectroscopy (NIRS) with vascular occlusion test. We also monitor temperature, heart rate, mean blood pressure, hemochrome, blood gases, blood lactates and SOFA score.

Detailed Description

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Conditions

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Septic Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fresh not-leukocyte-reduced RBCs

Group Type ACTIVE_COMPARATOR

Blood transfusion

Intervention Type BIOLOGICAL

RBCs have been transfused in septic patient admitted in ICU

Fresh RBCs leukocyte-reduced

Group Type ACTIVE_COMPARATOR

Blood transfusion

Intervention Type BIOLOGICAL

RBCs have been transfused in septic patient admitted in ICU

RBCs with storage longer than 15 days

Group Type ACTIVE_COMPARATOR

Blood transfusion

Intervention Type BIOLOGICAL

RBCs have been transfused in septic patient admitted in ICU

Interventions

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Blood transfusion

RBCs have been transfused in septic patient admitted in ICU

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients with sepsis, severe sepsis or septic shock who, according to clinical evaluation, need a hemotransfusion.

Exclusion Criteria

* Patients under 18 years of age; Pregnancy; Coagulative disorders; Cardiogenic shock (Met\<4;)Acute massive bleeding (\>8 U)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero, Universitaria Ospedali Riuniti

OTHER

Sponsor Role collaborator

Università Politecnica delle Marche

OTHER

Sponsor Role lead

Responsible Party

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Abele Donati, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abele Donati, MD

Role: PRINCIPAL_INVESTIGATOR

Università Politecnica delle Marche

Locations

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University ICU, AOU Ospedali Riuniti

Torrette Di Ancona, Ancona, Italy

Site Status

Countries

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Italy

References

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Damiani E, Adrario E, Luchetti MM, Scorcella C, Carsetti A, Mininno N, Pierantozzi S, Principi T, Strovegli D, Bencivenga R, Gabrielli A, Romano R, Pelaia P, Ince C, Donati A. Plasma free hemoglobin and microcirculatory response to fresh or old blood transfusions in sepsis. PLoS One. 2015 May 1;10(5):e0122655. doi: 10.1371/journal.pone.0122655. eCollection 2015.

Reference Type DERIVED
PMID: 25932999 (View on PubMed)

Donati A, Damiani E, Luchetti M, Domizi R, Scorcella C, Carsetti A, Gabbanelli V, Carletti P, Bencivenga R, Vink H, Adrario E, Piagnerelli M, Gabrielli A, Pelaia P, Ince C. Microcirculatory effects of the transfusion of leukodepleted or non-leukodepleted red blood cells in patients with sepsis: a pilot study. Crit Care. 2014 Feb 17;18(1):R33. doi: 10.1186/cc13730.

Reference Type DERIVED
PMID: 24528648 (View on PubMed)

Other Identifiers

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Prot 210163

Identifier Type: -

Identifier Source: org_study_id

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