NCT01584999

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

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

February 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

April 23, 2012

Last Update Submit

May 21, 2012

Conditions

Septic Patients

Outcome Measures

Primary Outcomes (1)

  • Microcirculatory Flow Index (MFI) before and after blood transfusion.

    Microcirculatory Flow Index detected in vivo by side-dark field imaging at sublingual microcirculation. It represents the quality of blood flow at microcirculatory level. This study wants to verify any of the considered different types of blood transfused can improve MFI.

    One hour after the end of blood transfusion compared with before blood transfusion

Secondary Outcomes (5)

  • Perfused Vessel Density (PVD)

    One hour after the end of blood transfusion compared with before blood transfusion

  • StO2 upslope

    One hour after the end of blood transfusion compared with before blood transfusion

  • Arterial Blood Lactate

    One hour after the end of blood transfusion compared with before blood transfusion

  • Arterial pH

    One hour after the end of blood transfusion compared with before blood transfusion

  • SOFA score

    One hour after the end of blood transfusion compared with before blood transfusion

Study Arms (3)

Fresh not-leukocyte-reduced RBCs

ACTIVE COMPARATOR
Biological: Blood transfusion

Fresh RBCs leukocyte-reduced

ACTIVE COMPARATOR
Biological: Blood transfusion

RBCs with storage longer than 15 days

ACTIVE COMPARATOR
Biological: Blood transfusion

Interventions

Blood transfusionBIOLOGICAL

RBCs have been transfused in septic patient admitted in ICU

Fresh RBCs leukocyte-reducedFresh not-leukocyte-reduced RBCsRBCs with storage longer than 15 days

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University ICU, AOU Ospedali Riuniti

Torrette Di Ancona, Ancona, 60126, Italy

Location

Related Publications (2)

  • 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.

    PMID: 25932999DERIVED

  • 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.

    PMID: 24528648DERIVED

MeSH Terms

Interventions

Blood Transfusion

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Abele Donati, MD

    Università Politecnica delle Marche

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 25, 2012

Study Start

February 1, 2011

Primary Completion

February 1, 2012

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

IT(1)