NCT02310113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

December 3, 2014

Last Update Submit

December 5, 2014

Conditions

Anemia

Keywords

NIRStransfusionRBC

Outcome Measures

Primary Outcomes (1)

  • basal Sto2

    change of basal Sto2 of skeletal muscle after RBC transfusion

    1 hour

Secondary Outcomes (1)

  • vascular occlusion testing

    5 minutes

Study Arms (1)

Hematologic outpatients

Chronic anaemic outpatients who are planed to get transfusion RBC

Other: NIRS

Interventions

NIRSOTHER

Measurment of skeletal muscle oxygenation by near-infrared spectroscopy

Also known as: near infrared spectroscopy
Hematologic outpatients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hematologic anaemic patients

You may qualify if:

  • chronic haematologic patients

You may not qualify if:

  • pregnancy
  • rejection to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Anemia

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • matej podbregar, MD PhD

    UMC Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 5, 2014

Study Start

September 1, 2013

Primary Completion

August 1, 2014

Study Completion

December 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

SL(1)