ID
Source
Health condition
In this study the influence of the bloodcollectionsystem on laboratory results is studied on a number of specific laboratory tests.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Two collectionsystems (Greiner Bio-One and Becton Dickinson) are studied for specific laboratorytests. Results are evaluated in accordance to the CLSI Evaluation protocol number 9.
Secondary outcome
n.a.
Background summary
Rationale: The quality of the laboratory analyses performed to support either diagnostics or monitoring treatment of patients, is partly dependent of the quality of the blood collection system (needles) and the blood collection tubes used.
Objective: Comparison of laboratory analyses on plasma or serum obtained by different blood collection systems.
Study design: Comparative. Healthy volunteers will have blood drawn by two different blood collection systems ( Vacuette® , Greiner BioOne and Vacutainer®, Becton Dickinson). Various types of additives will be included in order to perform a spectrum of laboratory analyses. Statistical evaluation will be performed using the CLSI EP-9 protocol.
Study population: Patients and healthy volunteers of 18 years and older.
Study design
n.a.
Intervention
Not applicable.
Inclusion criteria
Healthy volunteers aged over 18 years (40 subjects)
Patients using vitamin K antagonists (20 subjects), Patients on heparin therapy (20 subjects) Patients with an decreased Von Willebrandfactor activity (5), protein C deficiency (5), protein S deficiency (5), Factor VIII deficiency (5) or factor IX deficiency (5).
Exclusion criteria
Patients having a decreased hemoglobin (Hb under 7.5 for women and Hb under 8.5 for men)
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7169 |
| NTR-old | NTR7392 |
| CCMO | NL66336.044.18 |
| OMON | NL-OMON48834 |