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

Università Politecnica delle Marche

Status and phase: Completed; Phase 4

Conditions: Septic Patients

Treatments: Biological: Blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01584999

Prot 210163

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

Fresh not-leukocyte-reduced RBCs

Active Comparator group

Treatment:

Biological: Blood transfusion

Fresh RBCs leukocyte-reduced

Active Comparator group

Treatment:

Biological: Blood transfusion

RBCs with storage longer than 15 days

Active Comparator group

Treatment:

Biological: Blood transfusion