Transfusion and Skeletal Muscle Tissue Oxygenation
|ClinicalTrials.gov Identifier: NCT02310113|
Recruitment Status : Completed
First Posted : December 5, 2014
Last Update Posted : December 8, 2014
|Condition or disease||Intervention/treatment|
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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|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|
Chronic anaemic outpatients who are planed to get transfusion RBC
Measurment of skeletal muscle oxygenation by near-infrared spectroscopy
Other Name: near infrared spectroscopy
- basal Sto2 [ Time Frame: 1 hour ]change of basal Sto2 of skeletal muscle after RBC transfusion
- vascular occlusion testing [ Time Frame: 5 minutes ]measuring of dynamic tissue oxygenaion
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310113
|Clinical Center Ljubljana|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||matej podbregar, MD PhD||UMC Ljubljana|