Hematological DiseasesNCT00390988
Capillary and Venous Blood Count Parameters
An observational study of Hematological Diseases and Healthy Volunteers, run by University of Magdeburg.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematological Diseases, Healthy Volunteers
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with haematological diseases ≥18 years
- Healthy volunteers ≥18 years
- Informed consent
- No participation in another study 3 month before and during the study
Who cannot join
- Subjects <18 years
- Healthy subjects with acute or chronic infections and autoimmune or malignant diseases
About this study
Official title: 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.
Read the 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.
- Conditions
- Hematological Diseases, Healthy Volunteers
- Being tested
- blood sampling
- Keywords
- blood count, capillary, venous, Adult, reference values
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hematological DiseasesStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Investigators
- Kathleen Jentsch-Ullrich, Dr., Principal investigator, University Hospial Magdeburg, Division of Haematoloy/Oncology, Leipziger Str. 44, D-39120 Magdeburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00390988
- Sponsor's protocol ID
- MD FME 45/06
- Status last verified
- Feb 2009
- First submitted
- 20 Oct 2006
- Last updated
- 20 Feb 2009
- Results posted
- No
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.
PubMed 18070280Schalk 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.
PubMed 18306364
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Capillary and Venous Blood Count Parameters
- ClinicalTrials.gov ID
- NCT00390988
- Acronym / sponsor ID
- MD FME 45/06
- Conditions
- Hematological Diseases, Healthy Volunteers
- Keywords
- blood count, capillary, venous, Adult, reference values
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- First posted
- 23 Oct 2006 (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 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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with haematological diseases ≥18 years
- Healthy volunteers ≥18 years
- Informed consent
- No participation in another study 3 month before and during the study
Key exclusion criteria (2 listed)
- Subjects <18 years
- Healthy subjects with acute or chronic infections and autoimmune or malignant diseases
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 |
|---|---|---|
| blood sampling | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 20 Feb 2009.
- Results publication: PubMed 18070280Schalk 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.
- Results publication: PubMed 18306364Schalk 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.
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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.
Kathleen Jentsch-Ullrich, Dr. principal investigator
University Hospial Magdeburg, Division of Haematoloy/Oncology, Leipziger Str. 44, D-39120 Magdeburg, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Hematological Diseases and Healthy Volunteers, run by University of Magdeburg.
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 4 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 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00390988, which also lists 2 linked publications.
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 20 Feb 2009.