XVIII Congress of the Italian Society for Hemostasis and Thrombosis Research, Rome, Sept. 30-Oct. 3, <strong>2004</strong>181methods. Seven outpatient peripheral units from theINHS were identified. Three hundred unselectedpatients referring to the Thrombosis Centre (TC) ofPerugia were enrolled on a first come basis afterobtaining informed consent. As a control group, westudied a series of matched patients of the TC. ThePoint-of-care (POC) device for the capillary determinatio<strong>no</strong>f INR was the Protime Microcoagulation System(IL, Milan), while the software used to manageOAT was P.A.R.M.A. 5 (IL, Milan, Italy). The project wasplanned and conducted with a research grant given byRegion Umbria. Results. Patients recruitment startedon October 2002 and fifty patients were assigned toeach unit. Five patients asked to withdraw. The meannumber of monthly accesses was 1.5 per patient. Theanalysis of the INR values showed that 62.1% of controlswere in the therapeutic range and that 72.0% oftime was spent within the therapeutic range. Neithermajor bleedings <strong>no</strong>r thromboembolic complicationswere documented. Interpretation and conclusions.These figures were <strong>no</strong>t different from those measuredin the control group and in the historical analysis ofthe study group confirming the feasibility of this typeof management of OAT.PO-170QUALITY CONTROL PROGRAMS FOR POC DEVICES TOMEASURE INR. RESULTS OF A PILOT EXERCISEFerrante F, Paccamiccio E, Servettini I, Iorio ASezione di Medicina Interna e Cardiovascolare –Università di Perugia, ItalyBackground. INR testing is usually performed onve<strong>no</strong>us plasma with automated coagulometers, andmany external and internal quality controls programare available. To date, several studies have demonstratedthat Point-Of-Care (POC) coagulation monitorsrepresent an attractive and efficient option forOAT monitoring, but specific quality controls programsare to be validated. Aim of the study: Set up,run and evaluate a quality control program for INR-POC measurements. Materials and Methods. Ten POCdevices (ProTime, IL, Milan) are routinarily used forINR determination in 350 patients over seven outpatientsservices. Four time a year, five randomlyselected patients from each service gave their consentto undergo both fingerstick and venipuncture.The device was then recalled in the coordinating laboratory,checked with control material (Direct-check,IL, Milan) by a skilled technician, and rotated toa<strong>no</strong>ther service following a randomized scheme.Ve<strong>no</strong>us PT-INR was performed in duplicate in twodifferent laboratories (using one MLA – Recombiplastinand the other Futura – Recombiplastin, allfrom IL, Milan). Correlation coefficients, Bland andAltman comparison, and ANOVA were used toanalyse the data. Results. Sixty two couples of datawere available at the end of April. No effect of service,instrument and sample was found. Main resultsare shown in the table.Mean Mean SD Agreement Range R 2of means of means limitsProtime vs lab1 2.54±0.91 0.49±0.66 -0.8 to + 1.78 -0.3 to +3.6 0.70Protime vs lab2 2.70±1.03 0.129±0.38 -0.624 to +0.882 -0.9 to +1.9 0.88Lab1 vs lab2 2.47±0.84 0.33±0.56 -0.77 to + 1.42 -0.2 to +2.7 071Mean SD 95%CI Range CV %Control low 1.631 .2496 1.08 to 2.18 1.3 to 1.9 15Control high 3.32 .606 2.12 to 4.51 3.0 to 4.0 18Conclusions. POC results are comparable to thoseof a clinical laboratory. Direct-check showed a CVsuitable for its use as control materials.PO-171DETERMINATION OF THE TECHNIQUE- AND SPECIMEN-SPECIFIC INTERNATIONAL SENSITIVITY INDEX FOR THETHROMBOTESTTM REAGENTChantarangkul V, 1 Frontoni R, 2 Gresele P, 3 Oca G, 4Paniccia R, 5 Pellegrini L, 6 Tripodi A 11A Bianchi Bo<strong>no</strong>mi Hemophilia and ThrombosisCenter, University and IRCCS Maggiore Hospital,Mila<strong>no</strong>; 2 Laboratorio di Coagulazione, Dipartimentodi Patologia Clinica, Ospedale di Macerata; 3 Dipartimentodi Medicina Interna, Sezione di MedicinaInterna e Cardiovascolare, Universita’ di Perugia;4U.O. Angiologia e Malattie della Coagulazione,Policlinico S. Orsola - Malpighi, Bologna; 5 CentroTrombosi, Azienda Ospedaliera Universitaria Careggi,Florence; 6 Servizio Trasfusionale, ASL1-Umbra,Citta’ di Castello, ItalyISI values for 3 different lots of ThrombotestTM,(Axis-Shield PoC, Oslo, Norway) were estimated usingboth the manual (tilt-tube) technique and the Thrombotrackselect 2 (Axis-Shield PoC, Oslo, Norway)coagulometer. The calibration has been divided into2 steps. First, Thrombotest Lot1 was calibratedagainst the WHO-International Standard codedOBT/79 using citrated plasma in 2 expert laboratoriesthat used both the manual technique and Thrombotrack.Second, Thrombotest Lot 2 and 3 were calibratedagainst Thrombotest Lot 1 in other 4 laboratoriesthat used only Thrombotrack. In this secondstep, testing was performed using both citrated plas-haematologica vol. <strong>89</strong>(suppl. n. 8):september <strong>2004</strong>
182Postersma and native whole blood. Both calibration exerciseshave been performed according to the WHO guidelines(WHO Technical 48th report, 1999). Briefly, prothrombintime for 60 patients on oral anticoagulantsand 20 healthy individuals has been performed in 10different working sessions. ISI-manual obtained inthis study for plasma with Lot 1 (0.99) was similar tothat declared by the manufacturer (0.98), but the ISI-Thrombotrack (0.91) was 8% lower. ISI-Thrombotrackfor Lot 2 and Lot 3 were similar to that of Lot 1, thedifferences being 75 yrs; main indications for OAT: AF 41%, valvularprosthesis 20%, DVT/PE 13%. The table displays theresults comparing pts. < 75 yrs and > 75 yrs (qualityanalysis on 735 pts), mean follow-up 248 days.All pts Pts < 75 yrs Pts ≥ 75 yrs p #Number of pts 925 496 (53.6%) 429 (46.4%)Death due to bleeding complications 0 0 0Major bleeding 4 (0.6%y/pts) 1 (0.3%y/pts) 3 (1.0%y/pts) 0.517Mi<strong>no</strong>r bleeding 36 (5.7%y/pts) 14 (4.2%y/pts) 22 (7.5%y/pts) 0.101Thrombotic events 18 (2.8%y/pts) 6 (1.8%y/pts) 12 (4.1%y/pts) 0.132INR within range 74.9% 73.4% 76.6% 0.361INR above range 13.8% 14.1% 13.4%INR below range 11.2% 12.3% 9.9%#between groups (< 75 yrs - ≥ 75 yrs) analysis; %y/pts = % year/patient.Conclusions: The management of patients in a ACimproves the treatment quality also in elderlypatients. The incidence of complications in our AC iscomparable to those of reference trials. In the elderly,OAT quality was similar to the younger but complicationstended to increase (<strong>no</strong>t significantly), suggestinga closer monitoring of these patients.PO-173EXTERNAL QUALITY ASSESSMENT PROGRAM FORCOAGULATION: THE EXPERIENCE OF EMILIA-ROMAGNAREGIONLudovici S, Legnani C,* Poggi M,* Franceschetti F,Incorvaia LR, Maltoni P, Mimmi P, Tancredi MA,Capelli MGruppo Controllo di Qualità Analitico, * U.O. diAngiologia e Malattie della Coagulazione “Mari<strong>no</strong>Golinelli”, Azienda Ospedaliera di Bologna,Policlinico S. Orsola-Malpighi, Bologna, ItalyThe external quality assessment program of theEmilia-Romagna region was created in 1987 and in1990 was extended to coagulation tests. Currently,244 Italian labs either from national health (n=74)or private (n=170) services are participating in theprogram. The program uses lyophilized human plasmaspecimens locally prepared in large, stable, uniformlots, which are distributed as unk<strong>no</strong>wn specimensto participants for analysis and generation ofinter-laboratory data. The participants are asked tohandle the distributed specimens using their routinemethods for the determination of Prothrombin Time,activated Thromboplastin Time, Fibri<strong>no</strong>gen and Antithrombin.Participants receive 12 specimens/year in6 cycles each of whom include one <strong>no</strong>rmal and onepathological specimen. Thrombophilia tests are goingto be included within the end of 2005. Results arereported using standard report forms, includinginformation on the assay principle, method andequipment used. Data are elaborated separately forhaematologica vol. <strong>89</strong>(suppl. n. 8):september <strong>2004</strong>