Embedding Point of Care monitoring (ROTEM) in daily practice

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1 Embedding Point of Care monitoring (ROTEM) in daily practice Yvonne Henskens Clinical chemist Head of unit General Hematology, Hemostasis and Transfusion Central Diagnostic Laboratory

2 Road to ROTEM 2009

3 Our clinicans were not satisfied Blood products were ordered, based on expert opions and not based on protocols or hemostatic tests NOT CLINICALLY USEFULL NOT SENSITIVE NOT SPECIFIC

4 Goal: BETTER and FASTER laboratory tests for bleeding patients in our hospital.

5 How FAST are our traditional Laboratory Tests??

6 Theoretical Turn Around Time (TAT) Step 1. From indication to order and blood drawing Hemoglobin Platelet count?? APTT, PT, Fibrinogen 2. Transport tot laboratory 2 min 2 min 3. Register order into LIS 5 min 5 min 4. Centrifugation step min 5. Preparation of analysis 5 min 5 min 6. Analysis 3 min 3 min 7. Technical validation of result 16 minutes 26 minutes 3 min 3 min

7 REALITY FIGURES OF TAT (2012) Median (IQR) in minutes STAT SUPER STAT Platelet count 26 (13-63) 13 (9-22) Fibrinogen 61 (48-82) 37 (31-54)

8 Definition of BETTER Laboratory Tests Clinically useful Diagnostic accuracy and precision Easy and correct interpretation of test results

9 Accuracy and precision Henskens/Zwolle/2013

10 Literature on precision of TEG or ROTEM is not very promising! Quality assurance and quality control of thrombelastography and rotational Thromboelastometry: the UK NEQAS for blood coagulation experience. Kitchen DP et al, Seminar Thromb Hemos 2010 Variance between hospitals: 7.1 to 39.9% for TEG (n=18) 7.0 to 83.6% for ROTEM (n=10)

11 IMPLEMENTATION SCHEDULE 2009: VISITING BEST PRACTICES Copenhagen (Per Johanssen, TEG) London (Benny Sörensen, ROTEM) 2010: MAKING CHOICES TEG or ROTEM OR (bed side) or in CENTRAL LAB : VALIDATION and IMPLEMENTATION 2011: START in PATIENTCARE

12 POCT equipment in central lab: WHY? Rule of Health Care Inspectorate (IGZ) in The Netherlands and Policy of our hospital Only use bedside testing when strictly necessary Results in the hospital information system All bedside tests are quality controlled by the central lab Staff has to be (re)trained by central lab Good collaboration and communication between anesthesiology, hematology and central laboratory

13 Distribution of POCT equipment in MUMC+ Central Laboratory Bedside (OR, ER, Ward) Blood gas analyzers (3) Blood gas analyzers (3) Verify Now (1) Coaguchek (3) Platelet Function Analyzer (1) Glucose meters (23) Multiplate (2) Hemocue (2) ROTEM (2) Team of 5 technician s

14 Validation procedure with 2 ROTEMs before starting in patient care (only cardiothoracic surgery)

15 Quality control of ROTEM Variation is between 1 and 8 % Parameters on ROTEM EXTEM Normal control sample EXTEM Abnormal control sample INTEM Normal control sample INTEM Abnormal control sample CT 4,3 5,2 2,3 4,2 Alpha 0,9 2,6 0,8 5,7 A5 4,8 4,1 5,3 8,3 A10 4,8 3,2 4,8 7,4 MCF 3,3 3,1 3,7 7,5

16 Pneumatic tube transport of ROTEM samples 100 MCF Maximum Clot Formation [mm] MCF_intem_tube MCF_intem_walk MCF_extem_tube MCF_extem_walk MCF_fibtem_tube MCF_fibtem_walk

17 ER ICU CENTRAL LAB OR RECOVERY Web-based IT connections Delivery ward

18 Tube transport (2 stations in OR) Henskens/Zwolle/2013

19 Trained technicians (n=20) Henskens/Zwolle/2013

20 OR: viewer function Henskens/Zwolle/2013

21 Live viewing AND data in HIS Henskens/Zwolle/2013

22 Cardio-OR (6 anesthesiologists and 8 perfusionists) Henskens/Zwolle/2013

23 TRAINING PHASE for interpretation Started with cardiothoracic surgery 3 ROTEM specialists for consultation Start with ROTEM use 5X8 Procedure for inclusion-interpretation-treatment Use all tests (ROTEM, platelets, APTT, PT, fibrinogen Evaluate results (repeat, repeat, repeat )

24 Conclusions after 18 months of ROTEM How many patients get a ROTEM analysis? What is de quality of the result after 18 months? Can we skip the traditional fibrinogen and platelet count? How fast is ROTEM? Can it be faster?

25 Increase in ROTEM analyses 15 % 10 % Average 1,5 ROTEM/patient

26

27 Transfusions and ROTEM (first year) Transfusions/ROTEMpatient Period 1 Period 2 Total Before first ROTEM order After first ROTEM order

28 QUALITY CONTROL NOW MCF CT MCF ROTEM 2 (mm) CT ROTEM 2 (Seconden) MCF ROTEM 1 (mm) Henskens/Zwolle/2013 CT ROTEM 1 (seconden) R 2 = 0,9926 R 2 = 0,9759 MCF Extem MCF Intem MCF Fibtem MCF Aptem MCF Heptem MCF CT Extem CT Intem CT Fibtem CT Aptem CT Heptem Lineair (MCF) CT Lineair (CT)

29 Step THEORETICAL Turn around time Hemoglobin Platelet count APTT, PT, Fibrinogen 1. Indication,order,bloodsample??? ROTEM 2. Transport tot laboratory 2 min 2 min 2 min 3. Order in LIS 5 min 5 min Centrifugation steps min Preparation of analysis 5 min 5 min 3 min 80 sec/test TOTAL 10! 6. Analysis 3 min 3 min CT 2 min CFT 5 min MCF 25 min 7. Technical validation of result 3 min 3 min Live viewing STEP 3-7: TOTAL in theory 16 min 26 min min

30 ROTEM-guided transfusion procedures Henskens/Zwolle/2013 Girdauskas E et al. J Thorac Cardiovasc Surg Nov;140(5): e2.

31 ROTEM-guided transfusion procedures Henskens/Zwolle/2013 Gorlinger K et al. Anesthesiology 2011; 115:

32 Amplitude after 5 minutes MCF A10

33 A5 in comparison to conventional tests EXTEM A5 EXTEM A10 EXTEM MCF FIBTEM A5 FIBTEM A10 Trombocyten 0,75 0,74 0, Fibrinogeen ,88 0,88 0,88 FIBTEM MCF

34 Turnaround time (TAT) in PRACTICE Median (IQR) (min) STAT SUPER STAT Platelet count 26 (13-63) 13 (9-22) Fibrinogen 61 (48-82) 37 (31-54) ROTEM A5 17 (16-21)

35 PLTEM EXTEM - FIBTEM EXTEM A5 Henskens/Zwolle/2013 EXTEM A10 EXTEM MCF PLTEM A5 PLTEM A10 Platelets 0,75 0,74 0,70 0,88 0,87 0,81 PLTEM MCF

36 Quality plans for 2013 ECAT (Piet Meijer) External Quality Control PROGRAMME 17 participating laboratories (6 OR and 11Lab) 18 ROTEMs 11 TEGs

37 ONE tube of blood gives you information on 1. Clotting factors and clot formation speed (CT, CFT) 2. Fibrinogen (FIBTEM) 3. Platelet count (PLTEM) 4. Fibrinolysis (APTEM) 5. Heparin (HEPTEM) Hematocrit has to be measured on a bedside POCTmeter (blood gas analyzer)

38 Complete ROTEM based treatment of all bleedings

39 Rick Wetzels Rene van Oerle Paul Verhezen Yvonne Henskens BTCIE PATIENT Erik Beckers Marcus Lancé Esther Bouman Geert Jan Kuiper Patrick Weerwindt Liesbeth Scheepers

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