AnemiaNCT02310113
Transfusion and Skeletal Muscle Tissue Oxygenation
An observational study of Anemia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anemia
- What is being tested?
- NIRS
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- Sep 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hematologic anaemic patients
Who may be able to join
- chronic haematologic patients
Who cannot join
- pregnancy
- rejection to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Red Blood Cell Transfusion and Skeletal Muscle Tissue Oxygenation in Anaemic Haematologic Outpatients
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.
- Conditions
- Anemia
- Being tested
- NIRS
- Keywords
- NIRS, transfusion, RBC
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSOther
Also called near infrared spectroscopy
Measurment of skeletal muscle oxygenation by near-infrared spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Hematologic outpatients | Chronic anaemic outpatients who are planed to get transfusion RBC Receives: Other: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
basal Sto2
change of basal Sto2 of skeletal muscle after RBC transfusion
Measured: 1 hour
Secondary outcomes (1)
vascular occlusion testing
measuring of dynamic tissue oxygenaion
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency
- Responsible party
- Principal investigator, Podbregar Matej, University Medical Centre Ljubljana
- Investigators
- matej podbregar, MD PhD, Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310113
- Sponsor's protocol ID
- Anemia_NIRS
- Status last verified
- Dec 2014
- First submitted
- 3 Dec 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Transfusion and Skeletal Muscle Tissue Oxygenation in Anaemic Haematologic Outpatients
- ClinicalTrials.gov ID
- NCT02310113
- Acronym / sponsor ID
- Anemia_NIRS
- Conditions
- Anemia
- Keywords
- NIRS, transfusion, RBC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Slovenian Research Agency
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematologic outpatients | – | Other: NIRSChronic anaemic outpatients who are planed to get transfusion RBC |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hematologic anaemic patients
Key inclusion criteria (1 listed)
- chronic haematologic patients
Key exclusion criteria (2 listed)
- pregnancy
- rejection to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRSAlso: near infrared spectroscopyMeasurment of skeletal muscle oxygenation by near-infrared spectroscopy | Other | Hematologic outpatients |
Primary outcome
basal Sto2
Time frame: 1 hour
change of basal Sto2 of skeletal muscle after RBC transfusion
1 secondary outcome
vascular occlusion testing
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
matej podbregar, MD PhD principal investigator
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
basal Sto2 (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.