Manufactures are responsible for repair and maintenance of the devices. At the University Hospital Bonn, trained users are responsible for patient samples, control sample measurements and refilling, emptying and ordering of consumables. Management of devices and back-up devices, user administration, hotline support, current device status, statistics of performance and checking for outliers also lie within the responsibility of the POCT coordination. Further, the POCT coordination is responsible for user training user-to-user instruction is not permitted. At the University Hospital Bonn, three responsibility levels have been implemented: The medical director of the central laboratory and the POCT coordination are responsible for internal and external quality controls according to current legal regulations. We previously published our legally binding and law conforming POCT concept with a detailed description of responsibility levels, training conditions, quality control schemes and functions of the POCT commission. POCT concept at the University Hospital Bonn The study design is consistent with the Declaration of Helsinki. As stipulated in article six of the German Data Protection Act ( ), the physician may use existing patient data for retrospective analyses without explicitly asking for the consent of patients. Therefore, according to prior agreement with the local ethics committee and the data protection officer appointed by the University Clinics Bonn, verbal or written informed consent was not obtained. All collected clinical data evaluated in this study were fully anonymized before analysis.
#Inr normal range with acute stroke professional#
Racké, MD, PhD, Professor, University Bonn, Germany) confirmed that the retrospective analysis of data obtained during routine treatment and diagnosis does not require consultation by the ethics commission according to §15 of the medical professional code. Accordingly, our local ethic commission (Chairman K. There was no additional collection of blood samples. POCT as well as central laboratory samples were obtained as part of routine diagnosis. The study is a single-center retrospective observational study. The guideline of the German Medical Association (Richtlinie der Bundesärztekammer, RiliBAEK) details all statutory requirements for quality control in POCT. However, not all POCT devices fulfill the legally stipulated requirements. Proper training in POCT use and adherence to all internal and external quality control requirements is crucial not only for coagulation measurement, but all POCT measurements. Therefore, known factors influencing POCT coagulation values, such as microaggregates, hematocrit variations and changes in plasma/cellular ratios, need to be considered by the clinician. Regarding POCT analysis of INR, it is important to consider that POCT devices for coagulation measurements deal with whole blood, whereas central laboratory analyzers use plasma.
Reliable POCT-INR values are mandatory for thrombolysis not only at hospital stroke units, but also in recently developed mobile stroke units or pre-hospital settings. Point-of-Care testing (POCT) is expected to reach this aim since the main advantages of POCT are reduced transport times and sample preparation procedures. Reducing door-to-needle time is one of the aims of the guidelines for managing acute ischemic strokes given that studies demonstrated health benefits when reducing thrombolysis delays. This important cut-off is crucial in the decision-making process regarding thrombolysis in ischemic stroke patients. Guidelines refer to studies, which showed that an INR ≤1.7 revealed no elevated risk of hemorrhage in patients with acute ischemic stroke. A laboratory analysis of, inter alia, International Normalized Ratio (INR) is mandatory in patients with acute stroke taking vitamin K-antagonists. However, contraindications must be strictly considered when evaluating whether thrombolysis is an option. Although diagnosis and therapies have improved over time, thrombolysis with tissue plasminogen activators remains one gold standard therapy option within the first four hours after the ischemic event. Stroke is one of the leading causes of death worldwide and a great global burden.
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