Pilot study comparing venous and capillary blood to analyze laboratory parameters in patients with rheumatoid arthritis
Organizational Data
- DRKS-ID:
- DRKS00023526
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2020-11-06
- Last update in DRKS:
- 2020-11-06
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The aim of this pilot study is to analyze whether venous and capillary blood in patients with rheumatoid arthritis leads to comparable laboratory results (rheumatoid factor IgM titer and CCP IgG antibody titer). The required blood collection time, blood volume, capillary collection location (upper arm / fingertip) and patient acceptance should also be analyzed. Venous blood collection by medical personnel serves as the gold standard. In addition, capillary blood is drawn by the patient: block randomization in blocks of 10 (group 1: capillary blood collection from the upper arm of choice; group 2: capillary blood collection from a fingertip of choice).
Brief summary in scientific language
Quantitative laboratory tests are essential for the diagnosis and precise monitoring of patients with inflammatory rheumatic diseases (RMD) such as rheumatoid arthritis (RA). The blood samples required for this are currently being obtained by venipuncture. This procedure is costly and time-consuming as the patient has to present himself to the clinic / practice. The venipuncture does not succeed immediately in all patients and sometimes several painful attempts are necessary. Another disadvantage of venipuncture is that the patient cannot draw blood independently. The result is also not available at the time of the visit and must be evaluated and discussed afterwards.
Health condition or problem studied
- ICD10:
- M05 - Seropositive rheumatoid arthritis
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Capillary blood collection from the upper arm (TASSO-SST)
- Arm 2:
- Capillary blood collection at the fingertip (BD Microtainer)
Endpoints
- Primary outcome:
- • Rheumatoid factor IgM titer and CCP IgG antibody titer from venous blood and capillary blood from the upper arm • Rheumatoid factor IgM titer and CCP IgG antibody titer from venous blood and capillary blood from the fingertip
- Secondary outcome:
- • Acceptance of capillary blood sampling from the upper arm (net promoter score, system usability scale) • Acceptance of capillary blood sampling at the fingertip (net promoter score, system usability scale) • Duration of the capillary blood collection from the upper arm (seconds) • Duration of the capillary blood collection from the fingertip (seconds) • Duration of venous blood collection (seconds) • Pain of capillary blood sampling from the upper arm (visual analogue scale 0-10) • Pain of capillary blood sampling from the upper arm (visual analogue scale 0-10) • Pain of capillary blood sampling from the fingertip (visual analog scale 0-10) • Resulting blood volume from the upper arm (µl) • Resulting blood volume from the fingertip (µl)
Study Design
- Purpose:
- Diagnostic
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Medizinische Klinik 3 Erlangen
Recruitment period and number of participants
- Planned study start date:
- 2020-11-08
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 50
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - Fulfillment of the EULAR / ACR RA classification criteria - The patient speaks fluent German - Previous detection of RF or CCP antibodies
Exclusion Criteria
The patient is unwilling or unable to participate in the study.
Addresses
Primary Sponsor
- Address:
- Medizinische Klinik 3, Universitätsklinikum ErlangenDr. med. Johannes KnitzaUlmenweg 1891054 ErlangenGermany
- Telephone:
- +4991318534742
- Fax:
- +4991318536448
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin3.uk-erlangen.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Medizinische Klinik 3Dr. med. Johannes KnitzaUlmenweg 1891054 ErlangenGermany
- Telephone:
- +4991318534742
- Fax:
- +4991318536448
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin3.uk-erlangen.de/
Contact for Public Queries
- Address:
- Medizinische Klinik 3, Universitätsklinikum ErlangenDr. med. Johannes KnitzaUlmenweg 1891054 ErlangenGermany
- Telephone:
- +4991318534742
- Fax:
- +4991318536448
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin3.uk-erlangen.de/
Principal Investigator
- Address:
- Medizinische Klinik 3Dr. med. Johannes KnitzaUlmenweg 1891054 ErlangenGermany
- Telephone:
- +4991318534742
- Fax:
- +4991318536448
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin3.uk-erlangen.de/
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Thermo Fisher Scientific79104 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Universität Erlangen-NürnbergKrankenhausstr. 1291054 ErlangenGermany
- Telephone:
- +40-9131-8522270
- Fax:
- +49-9131-8526021
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-07-20
- Ethics committee number:
- 320_20B
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-08-12
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry