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    UHP ROTEM Implementation

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    UHP ROTEM implementation

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    UHP ROTEM Implementation

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    of 30

    UHP MOH ALGORITHM

    ROTEM DRIVEN TRANSFUSION MANAGEMENT


    Dr Daryl Thorp-Jones
    Dr Stuart Cleland
    Caroline Lowe
    2019
    AIMS

    (1) MOH. Definition, Incidence and Impact on critical care


    (2) Impact of Maternal Physiology on Massive Haemorrhage
    (3) The EBM behind the use of fibrinogen concentrate and
    ROTEM
    (4) HOW UHP does it! Algorithm
    (5) Our successes so far
    (6) Future change/ Lessons learned
    ICNARC OBSTETRIC ADMISSIONS

    11% of female admissions to critical care


    Antenatally (20%): Predominately Pneumonia
    Postnatally (80%): Predominantly PPH
    Obstetric admissions to critical care have a low mortality than matched
    controls (2 vs 11%)

    Female admissions (aged 16–50 years) to adult, general critical care units in England Wales and Northern Ireland, reported as

    ‘currently pregnant’ or ‘recently pregnant’. 1 January 2007 to 31December 2007. ICNARC 2009.
    •Previous SCASMM reports

    SCOTTISH CONFIDENTIAL AUDIT


    HAEMORRHAGE
    Scottish Confidential Audit of Severe Maternal
    Morbidity:
    MOH (>2500 mls) or 5 Units or Coagulopathy
    2005. 3.7 per 1000 births
    2012. 5.8 per 1000 births
    In 2012. MOH responsible for 80.1% of severe
    maternal morbidity in Scotland
    MASSIVE OBS HAEMORRHAGE
    (MOH)
    DEFINITION
    NO actual consensus
    Most institutions: 1500 mls OR 4g/dl HB drop after
    acute blood loss OR a transfusion of 4units +
    UHP.. Currently 1000 mls WITH ONGOING LOSSES
    (new protocol)
    RELEVANT PHYSIOLOGY
    Protective changes (against Haemorrhage)
    Cardiac output increase 40-50%
    SV by 25%
    Blood volume 70 ml/kg to 100 ml/kg
    FIBRINOGEN increases

    BUT
    Uterine Blood Flow at term 800 ml/min!
    Haemostasis can be challenging
    BLOOD MANAGEMENT
    Estimating blood loss is difficult – MEASURE!

    Cell salvage recommended if abnormal bleeding occurs


    during LSCS, advise leucocyte filter.

    Severe early consumptive coagulopathy is associated with:


     abruption
     amniotic fluid embolus
     severe bleeding with pre-eclampsia

    PPH due to atony/trauma unlikely to be associated with


    coagulopathy
    BLOOD MANAGEMENT
    Protocol-led use of blood products will often
    lead to overtransfusion of FFP:
     If coag unknown, 4 PRC’s before FFP
     After 4 PRC’s give 4 FFP.
     Maintain 1:1 ratio until results known.
     Point-of-care (POC) testing recommended.

    Hypofibrinogenaemia predicts risk of ongoing


    PPH
     Normal fibrinogen = 4–6 g/l
     < 3 and especially < 2 with bleeding predicts
    progression to major bleed
    UHP BLOOD PRODUCT USE PRE-ROTEM
    USING TRADITIONAL SHOCK PACKS
    18-19 Financial \Year
    MH Incidence just below 10/month
    1000-1500 mls approx. 20/month
    TXA/Fib/ROTEM Protocol starts from Feb 2019
    MTP trigger 1500 mls during this period
    1500 MLS PPH
    1500 mls MTP trigger (note taught in team training)
    MTP activation : 24/97 (24.7%)
    Blood transfusion 15/97 (15.4%). 2unit use the norm
    One use of fib concentrate (during 9 unit transfusion/2FFP/1 Plt)
    FFP use 4/97 (4%)
    FFP thawed/returned for used 6/97 (
    FFP wasted %
    DESTINATION OF FFP ISSUED
    In 10 month period before new protocol (April 18-Jan 19)

     24 units given
     29 returned to blood bank and re-issued
     10 units wasted

    Since new protocol – 2 months data

     0 units FFP given


     4 units returned to blood bank and re-issued
     2 units wasted
    OBSTETRIC HAEMORRHAGE + THE ROLE
    OF FIBRINOGEN
    Fibrinogen levels higher in pregnancy (~5g/dL)
     Physiological excess to prepare for peripartum haemorrhage

    Clauss Fibrinogen levels <3g/dL, in particular if <2g/dL, are


    associated with larger and more significant PPH. <1g/dl
    =Haemostatic failure!!
    FFP has a problem…ie a much lower fibrinogen content (1.5g/dl in
    FFP) than that seen in term parturients.
    Fib concentrate is the obvious answer. But needs guided administration
    re cost.
    POCCT IN OBSTETRIC HAEMORRHAGE
    Standard laboratory tests are slow and results may be irrelevant by
    the time of reporting (60mins)
    Cardiff and Liverpool ROTEM® work show direct correlation between
    FIBTEM A5 times and clauss Fibrinogen levels. Show decrease
    losses/decreased product use
    ROTEM® allows rapid real-time identification of coagulopathy and
    targeted transfusion of blood products
     EXTEM measures effect of extrinsic pathway
     FIBTEM measures effect of fibrinogen by eliminating effect of plt
     FIBTEM A5 closely correlates to max clot firmness (MCF) but have
    result for A5 more rapidly (5 minutes)

    Cardiff (2017): A5 >10mm. Time in HDU 11hrs vs 24 hrs

     R.E.Collis and P.W.Collins. Haemostatic management of obstetric haemorrhage. Anaesthesia 2015;70(supp 1):78-86.
     Collins PW, Cannings-John R, Brynseels D, Mallaiah S, Dick J, Elton C et al. Viscoelastometric-guided early fibrinogen
    concentrate replacement during post-partum haemorrhage: OBS2; a double-blind, randomised controlled trial. BJA
    2017;119(3):411-21.
    LIVERPOOL – KEY POINTS
    LWH using ROTEM POCCT routinely alongside the MOH protocol since 2011
    Fibrinogen concentrate used in Europe more than cryo
     ?safer, pasteurised, no thawing or cross-match necessary

    Compared use of ‘shock packs’ (4 PRC, 4 FFP, 1 Plt), to new algorithm using ROTEM-
    guided fibrinogen concentrate administration in obstetric patients with PPH >1500ml.
     Sig reduction in FFP, cryo + platelet transfusion
     Sig reduction in TACO
     Non-sig reduction in TRALI, hysterectomy,
     ICU admission (10% admission in shock pack vs 1% in Fibrinogen group)

    Note – study not powered for sig diff in all outcomes (e.g. hysterectomy) and therefore
    need RCT

    Mallaiah S, Barclay P, Harrod I, Chevannes C, Bhalla A. Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in
    major obstetric haemorrhage. Anaesthesia 2015;70:166-175.
    WOMAN TRIAL

    • 20,000 women
    • 1g TXA vs placebo
    • Reduction in death due to bleeding if
    given within 3 hours
    • Other cause death and rates of
    hysterectomy not affected
    • No increase in VTE or other adverse
    events

    • TXA should be given if:


    > 500 ml after a vaginal delivery
    > 1000 ml after LSCS

    Leading with excellence, caring with compassion


    A PERFECT STORM. CURRENT UHP
    ACTIVITY
    Consultant haematologist engaged and active on the project (Wayne
    Thomas at UHP)
    The presence of auditable use data and costings helped considerably
    (Engaged trainees: Pippa Squires and Chris Leighton)
    Existing evidence base for ROTEM in Obstetrics (as presented)
    HTC approved and engagement (Stu Cleland). Obs CG engaged
    Surgeons engaged
    Lab training and engagement. Dependent on Transfusion Practitioners
    (Caroline Lowe)
    2019 UHP MATERNAL HAEMORRHAGE
    Severe MH redefined as 1000mls with ONGOING losses (trying to
    prompt early intervention and MTP activation)
    Early TXA 1g promoted (in delivery room)
    Early 2nd citrated SAMPLE (for rotem)
    ROTEM driven Pathway. Emphasis of fibrinogen replacement
    IPL training/haemorrhage sim (via PROMPT and theme of the week)
    MOH ALGORITHM
    ROTEM ALGORITHM
    FIBRINOGEN CONCENTRATE
    Two products:
    (1) Haemocomplettan P (CSL Behring). All the evidence base and
    our algorithm using this at declared doses. Used in many MOH
    studies in Europe/known safety. Disadvantage: Slow to prepare
    however.
    (2) FibClot (LFB Biopharmaceuticals). Advantages. Increased viral
    inactivation procedures, Quicker preparation time, Increased
    bioavailability of fibrinogen so you give less to achieve
    comparable rises in fibrinogen levels. Long shelf-life (this stuff is
    expensive). Same price/cheaper than current preparations.
    Disadvantages: No Obstetric evidence base/altered doses in our
    PHNT algorithm
    IS IT WORTH IT?
    Too early to say but FFP use has dropped off in the trust overall in
    2019
    We now need to revisit the data
    PRESUMPTION: will be an impact on FFP use with a consequential rise
    in Fib Concentrate use
    Too early/too small in numbers to extrapolate further although
    incidence of ICU admissions POST PPH will be interesting to examine
    between 18-19 and 19-20 financial years
    CASE STUDY .
    •Primip, presented in labour following SROM ? Element PET.
    •04:16 - Vaginal birth following unremarkable labour.
    •04:34 – Placenta delivered, continuous trickle blood loss, uterus
    boggy.
    •04:55 - Hypotension/tachycardia - > Dx uterine inversion -> theatre
    (GA)
    • EBL estimate 1800ml, Hb 69 (133 pre-delivery)
    • 2 units PRBCs transfused intra-op, 1 more due to be given but stopped as spiked
    temperature.

    •12:45 – Hb 102 -> 71, spreading vulval haematoma – plan return to


    theatre.
    Pre-return to theatre – 2 units RBCs
    FIBTEM – A5 5

    Hb 72
    Plt 39
    INR 1.2
    EXTEM Fib 1.10
    Post-op – 3 further units RBCs + 2 cryo

    Hb 78
    Plt 27
    INR 1.2
    Fib 1.30
    D-dimer 4.30
    Further resuscitation – 2 units RBCs, 1 pool
    platelets, 2 FFP, 2 grams fib concentrate.

    Hb 87
    Plt 70
    INR 1.1
    Fib 2.7
    D-Dimer 0.8
    OUR EXPERIENCE SO FAR
    Anecdotal Evidence at Present… but

    Rapid correction of coagulopathy and stabilisation with Fib Concentrate


    when fib tem is low
    Fib Clot mixing slow BUT not as slow as thawing Cryo. Moving to new FASTER
    Fibclot
    Occasional resistance to issuing fib concentrate without formal clauss
    fibrinogen. Now dealt with!
    Review of mild reduction FIBTEM group (12-15). Thoughts are FFP NOT
    NEEDED
    FUTURE DEVELOPMENT AT UHP
    Fib-Clot 3g (two bottles ) rather than 2g. Easier to mix. UHP will switch
    once current Fib concentrate used
    Establishing new antenatal iron pathway (based on Kings Lynn
    pathway) to attempt to abolish anaemia at term/elective section
    The same team engaged in this!
    Our blood conservation strategy includes routine suction VIA ICS.
    Correct anti-D dosing remains an issue and is being targeted by team
    training/sign out changes
    CONTACT AND QUESTIONS
    Dr Daryl Thorp-Jones
    Consultant Obstetric Anaesthetist
    UHP Blood Conservation Lead
    [email protected]

    Dr Stuart Cleland
    Consultant Obstetric Anaestheist
    UHP HTC Chair

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