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Transfusion and Skeletal Muscle Tissue Oxygenation

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ClinicalTrials.gov Identifier: NCT02310113
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : December 8, 2014
Sponsor:
Collaborator:
Slovenian Research Agency
Information provided by (Responsible Party):
Podbregar Matej, University Medical Centre Ljubljana

Brief 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.

Condition or disease Intervention/treatment
Anemia Other: NIRS

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Red Blood Cell Transfusion and Skeletal Muscle Tissue Oxygenation in Anaemic Haematologic Outpatients
Study Start Date : September 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Hematologic outpatients
Chronic anaemic outpatients who are planed to get transfusion RBC
Other: NIRS
Measurment of skeletal muscle oxygenation by near-infrared spectroscopy
Other Name: near infrared spectroscopy




Primary Outcome Measures :
  1. basal Sto2 [ Time Frame: 1 hour ]
    change of basal Sto2 of skeletal muscle after RBC transfusion


Secondary Outcome Measures :
  1. vascular occlusion testing [ Time Frame: 5 minutes ]
    measuring of dynamic tissue oxygenaion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hematologic anaemic patients
Criteria

Inclusion Criteria:

  • chronic haematologic patients

Exclusion Criteria:

  • pregnancy
  • rejection to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310113


Locations
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Slovenia
Clinical Center Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Slovenian Research Agency
Investigators
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Principal Investigator: matej podbregar, MD PhD UMC Ljubljana
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Responsible Party: Podbregar Matej, Prof., University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02310113    
Other Study ID Numbers: Anemia_NIRS
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Podbregar Matej, University Medical Centre Ljubljana:
NIRS
transfusion
RBC