- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00390988
Capillary and Venous Blood Count Parameters
February 19, 2009 updated by: University of Magdeburg
Comparison of Capillary and Venous Blood Count Parameters
The purpose of this study is to compare capillary blood count parameters with the corresponding venous samples to verify the hypothesis that capillary and venous blood count parameters are equivalent.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In patients with haematological diseases regular blood count analyses are necessary.
In haematology, capillary blood count analyses became established in routine diagnostics.
The method and procedure of capillary blood sampling is well accepted by both the patients and the medical personal for a long time.
However, only venous values are generally accepted in clinical routine.
It is important to know whether or how capillary blood gives discrepant results for the various parameters.
Values for therapeutic decisions, e.g.
transfusion, are only known for venous values.
So far, there are only deficient data available.
Therefore, the aim of this study is (i) to compare capillary blood count parameters with the corresponding venous samples to verify the hypothesis that capillary and venous blood count parameters are equivalent, (ii) to include an adequate large number of adult haematological patients (with low and high values) and healthy adults, (iii) to obtain difference values for conversation of measured capillary values into the corresponding venous values.
Study Type
Observational
Enrollment
250
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with haematological diseases ≥18 years
- Healthy volunteers ≥18 years
- Informed consent
- No participation in another study 3 month before and during the study
Exclusion Criteria:
- Subjects <18 years
- Healthy subjects with acute or chronic infections and autoimmune or malignant diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathleen Jentsch-Ullrich, Dr., University Hospial Magdeburg, Division of Haematoloy/Oncology, Leipziger Str. 44, D-39120 Magdeburg, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schalk E, Heim MU, Koenigsmann M, Jentsch-Ullrich K. Use of capillary blood count parameters in adults. Vox Sang. 2007 Nov;93(4):348-53. doi: 10.1111/j.1423-0410.2007.00978.x.
- Schalk E, Scheinpflug K, Mohren M. Correlation of capillary and venous absolute neutrophil counts in adult hematological patients and normal controls. Am J Hematol. 2008 Jul;83(7):605. doi: 10.1002/ajh.21163. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 20, 2006
First Submitted That Met QC Criteria
October 20, 2006
First Posted (Estimate)
October 23, 2006
Study Record Updates
Last Update Posted (Estimate)
February 20, 2009
Last Update Submitted That Met QC Criteria
February 19, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD FME 45/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.