Transfusion and Skeletal Muscle Tissue Oxygenation

Anemia Clinical Trial

Official title:

Red Blood Cell Transfusion and Skeletal Muscle Tissue Oxygenation in Anaemic Haematologic Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310113
• Other study ID #: Anemia_NIRS
• Status: Completed
• Phase: N/A
• First received: December 3, 2014
• Last updated: December 5, 2014
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• chronic haematologic patients

Exclusion Criteria:

• pregnancy

• rejection to participate

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Intervention

Other:
• NIRS
Measurment of skeletal muscle oxygenation by near-infrared spectroscopy

Locations

Country	Name	City	State
Slovenia	Clinical Center Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	basal Sto2	change of basal Sto2 of skeletal muscle after RBC transfusion	1 hour	No
Secondary	vascular occlusion testing	measuring of dynamic tissue oxygenaion	5 minutes	No