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

Effects on the Septic Patient's Microcirculation of the Transfusion of Three Different Types of Concentrated Red Blood Cells.

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.

Study Overview

• Status: Completed
• Conditions: Septic Patients
• Intervention / Treatment: Biological: Blood transfusion

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fresh not-leukocyte-reduced RBCs	Biological: Blood transfusion; RBCs have been transfused in septic patient admitted in ICU
Active Comparator: Fresh RBCs leukocyte-reduced	Biological: Blood transfusion; RBCs have been transfused in septic patient admitted in ICU
Active Comparator: RBCs with storage longer than 15 days	Biological: Blood transfusion; RBCs have been transfused in septic patient admitted in ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One hour after the end of blood transfusion compared with before blood transfusion
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.	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

Collaborators and Investigators

• Sponsor: Università Politecnica delle Marche
• Collaborators: Azienda Ospedaliero, Universitaria Ospedali Riuniti
• Investigators: Principal Investigator: Abele Donati, MD, Università Politecnica delle Marche

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 25, 2012

Study Record Updates

• Last Update Posted (Estimate): May 23, 2012
• Last Update Submitted That Met QC Criteria: May 21, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: Prot 210163