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CompletedNCT01584999Updated May 23, 2012

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

A Phase 4 interventional study of Blood transfusion in Septic Patients, sponsored by Università Politecnica delle Marche. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-23.

Sponsored by Università Politecnica delle Marche · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Septic Patients
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In context

Lead sponsor

Università Politecnica delle Marche is the lead sponsor of 46 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Fresh not-leukocyte-reduced RBCs

    Biological: Blood transfusion

  • Active comparator
    Fresh RBCs leukocyte-reduced

    Biological: Blood transfusion

  • Active comparator
    RBCs with storage longer than 15 days

    Biological: Blood transfusion

Interventions

  • BiologicalBlood transfusion

    RBCs have been transfused in septic patient admitted in ICU

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What researchers measure

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.

    Time frame: One hour after the end of blood transfusion compared with before blood transfusion

Secondary outcomes

  1. Perfused Vessel Density (PVD)

    Perfused Vessel Density detected in vivo by side-dark field imaging at sublingual microcirculation. It represents the quantity of well perfused vessels at microcirculatory level. This study wants to verify any of the considered different types of blood transfused can improve PVD.

    Time frame: One hour after the end of blood transfusion compared with before blood transfusion

  2. StO2 upslope

    StO2 upslope is measured with Near InfraRed Spectroscopy at the tenar muscle. It represents the velocity of the recovery of the tissue oxygen saturation after a short period of ischemia of the hand, the Vascular Occlusion Test.

    Time frame: One hour after the end of blood transfusion compared with before blood transfusion

  3. Arterial Blood Lactate

    Time frame: One hour after the end of blood transfusion compared with before blood transfusion

  4. Arterial pH

    Time frame: One hour after the end of blood transfusion compared with before blood transfusion

  5. SOFA score

    Time frame: One hour after the end of blood transfusion compared with before blood transfusion

07

Study locations

1 site
  • University ICU, AOU Ospedali Riuniti
    Torrette di Ancona, Ancona 60126, Italy
08

References and documents

Publications

  • 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. PubMed 25932999 ↗
  • 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. PubMed 24528648 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01584999
Lead sponsor
Università Politecnica delle Marche
Collaborators
Azienda Ospedaliero, Universitaria Ospedali Riuniti
Responsible party
Abele Donati, MD (Associate Professor, Università Politecnica delle Marche) — Principal investigator
First posted
Apr 25, 2012
Start date
Feb 2011
Primary completion
Feb 2012
Last update
May 23, 2012

Study contacts

Abele Donati, MD
principal investigator · Università Politecnica delle Marche

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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