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CompletedNCT02310113Updated Dec 8, 2014

Transfusion and Skeletal Muscle Tissue Oxygenation

An observational study in Anemia, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-12-08.

Sponsored by University Medical Centre Ljubljana · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The aim of the present study was to re-challenge the current data that anaemia in chronically anaemic haematology patients is not associated with low skeletal muscle StO2, and that the age of RBCs does not influence tissue responses. The investigators investigated these aspects using improved technology NIRS devices, for deeper tissue penetration and removal of the superficial signal from the skin.

Read the detailed description

Anaemia is state of decreased blood oxygen carrying capacity . Acute anaemia is associated with increased tissue oxygen extraction . On the other hand, with chronic anaemia human body has time to at least partially adapt to decreased blood oxygen carrying capacity , .

Near-infrared spectroscopy (NIRS) is non-invasive method to assess tissue oxygenation (StO2) and estimate tissue haemoglobin (THb) levels . The investigators have studied skeletal muscle StO2 in critically ill patients with preserved oxygen (i.e., cardiogenic shock) and with impaired oxygen extraction (i.e., septic shock) , , . In addition to measuring resting StO2, the investigators performed vascular occlusion tests to stop arterial blood flow, to estimate oxygen consumption, and at the end of the occlusion, it was also possible to estimate vascular reactivity and maximal reperfusion capability .

Under acute blood loss in trauma patients, the skeletal muscle StO2 measured by NIRS correlates with blood haemoglobin (Hb) and delivery of oxygen, and can easily detect latent stage of haemorrhagic shock . Unexpectedly, chronically anaemic haematology patients with preserved oxygen extraction capability did not show low skeletal StO2 and THb index despite their severe anaemia, which is what would be predicted from normal physiological responses .

It is known that there are structural and functional changes to RBCs during storage. Recent study detected deleterious effects of RBC storage on microvascular responses to transfusion in stable anaemic trauma patients .

The aim of the present study was to re-challenge the current data that anaemia in chronically anaemic haematology patients is not associated with low skeletal muscle StO2, and that the age of RBCs does not influence tissue responses. The investigators investigated these aspects using improved technology NIRS devices, for deeper tissue penetration and removal of the superficial signal from the skin.

02

Conditions studied

  • Anemia

Keywords

  • NIRS
  • transfusion
  • RBC
03

In context

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hematologic anaemic patients

Inclusion criteria

  • chronic haematologic patients

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • rejection to participate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Hematologic outpatients

    Chronic anaemic outpatients who are planed to get transfusion RBC

    Other: NIRS

Interventions

  • OtherNIRS

    Measurment of skeletal muscle oxygenation by near-infrared spectroscopy

    Also known as: near infrared spectroscopy

06

What researchers measure

Primary outcomes

  1. basal Sto2

    change of basal Sto2 of skeletal muscle after RBC transfusion

    Time frame: 1 hour

Secondary outcomes

  1. vascular occlusion testing

    measuring of dynamic tissue oxygenaion

    Time frame: 5 minutes

07

Study locations

1 site
  • Clinical Center Ljubljana
    Ljubljana, 1000, Slovenia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02310113
Lead sponsor
University Medical Centre Ljubljana
Collaborators
Slovenian Research Agency
Responsible party
Podbregar Matej (Prof., University Medical Centre Ljubljana) — Principal investigator
First posted
Dec 5, 2014
Start date
Sep 2013
Primary completion
Aug 2014
Completion
Dec 2014
Last update
Dec 8, 2014

Study contacts

matej podbregar, MD PhD
principal investigator · UMC Ljubljana

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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