update on postpartum hemorrhage - lsanesthesia.org one pdf/1... · update on postpartum hemorrhage...

Update on Postpartum Hemorrhage

May 14, 2016

Georges Savoldelli

Associate Professor, Division of Anesthesiology

Geneva University Hospitals

Switzerland

“Obstetric catastrophes”No conflict of interest

Obstetric Hemorrhage

PPH is defined as a volume of blood loss :

• > 500 mL within 24h of vaginal delivery (VD)

• > 1000 mL within 24h of Cesarean delivery (CD)

• Remains the leading cause of maternal death worldwide

• Accounts for ≈ 30% of all direct maternal deaths

• ≈ 143’000 deaths/year due to PPH

During the time of this presentation approximately:

• ≈ 9 mothers will die

• ≈ 3 will die from hemorrhage

Ronsmans et al. Lancet 2006; 368: 1189–200

Solomon et al. BJA 2012; 109 (6): 851–63

Trends in maternal mortality: 1990 to 2015: estimates by WHO, UNICEF, UNFPA, World Bank Group and the United Nations Population Division.

Knight M et al. BMC Pregnancy Childbirth. 2009; 9: 55.

Trends in PPH in high resource countries

Knight M et al. BMC Pregnancy Childbirth. 2009; 9: 55.

Trends in PPH in high resource countries

The majority of death by PPH are preventableincluding in high resource countries

Contributing factors:Delay in diagnosisDelay in treatment

“too little” is done “too late”Deficiencies in organization

WHO analysis of causes of maternal death: a systematic review.

Lancet. 2006 Apr 1;367(9516):1066-74.

Plan

• Obstetric hemorrhage safety bundle

• Point of care coagulation testing

• Use of fibrinogen concentrates in PPH

• Use of prohemostatic drugs in PPH

• Conclusions

Obstetric Hemorrhage Safety Bundle

1. Readiness (Every Unit)

2. Recognition and Prevention (Every Patient)

3. Response (Every Hemorrhage)

4. Reporting and Systems Learning (Every Unit)

National Partnership for Maternal Safety, Council on Patient Safety in Women’s Health Care

Anesth Analg 2015;121:142–8 and http://www.safehealthcareforeverywoman.org


Readiness (Every Unit)

1. Hemorrhage cart with supplies

2. Immediate access to hemorrhage medications (kit or equivalent)

3. Establish a response team—who to call when help is needed

4. Establish massive and emergency-release transfusion protocol (type-O negative or uncrossmatched)

5. Unit education on protocols, unit-based drills (with postdrill debriefs)



Multidisciplinary team training using simulation and drills








Recognition and Prevention (Every Patient)

6. Assessment of hemorrhage risk (prenatal, on admission, and at other appropriate times)

7. Measurement of cumulative blood loss (formal, as quantitative as possible)

8. Active management of the 3rd stage of labor (department-wide protocol)



Improving blood loss assessment

Usefulness of a collecting bag for the diagnosis of post-partum hemorrhageJ Gynecol Obstet Biol Reprod 2004;33:229-34.

Blood loss assessment is improved but unfortunately its use in a RCT did not reduce the rate of severe PPH.BMJ 2010;340:c293












Response (Every Hemorrhage)

9. Stage-based obstetric hemorrhage emergency management plan with checklists

10. Support program for patients, families, and staff for all significant hemorrhages



Diagnostic, Tone

Organization

Coagulation

Tamponade

Invasive therapy

Hysterectomy

Girard et al. Curr Opin Anesthesiol 2014, 27:267–274















Reporting and Systems Learning (Every Unit)

11. Establish a culture of briefings for high-risk patients and postevent debriefs to identify successes and opportunities

12. Multidisciplinary review of serious hemorrhages for systems issues

13. Monitor outcomes and indicators in perinatal quality improvement committee

















Reporting and Systems Learning (Every Unit)

11. Establish a culture of briefings for high-risk patients and postevent debriefs to identify successes and opportunities

12. Multidisciplinary review of serious hemorrhages for systems issues

13. Monitor outcomes and indicators in perinatal quality improvement committee



“ The goal of this safety bundle is to reduce

the frequency of severe hemorrhages and

improve maternal outcomes. The bundle is

inherently multidisciplinary and is designed

to assist in establishing a culture of safety.

…we recognize the need to individualize the

specific details of these protocols to fit

available resources…”

Plan





• Conclusions

PPH

Causes of PPH: 4T's Mnemonic

Tone≈ 70 % of all PPH causes

Thrombin

Tissue Trauma

Primary coagulopathies

account for ≈ 1% of PPH

However, secondary coagulopathy

develops quickly in severe PPHSolomon et al. BJA 2012 109 (6): 851–63

Rotational Thromboelastometry (ROTEM®) in pregnancy

Increase in the “capacity to coagulate”

De Lange et al. BJA 2014

ANTEPARTUM IMMEDIATE POSTPARTUM

BJOG. 2009 Jul;116(8):1097-102

CA5 ≤ 5 mm and CA15 ≤ 6 mm :Detect fibrinogen level < 1.5 g/l in PPH

Sensitivity (100% for both parameters) Specificity (85 and 88% respectively)

Early parameters obtained from the FIBTEM test correlate well with fibrinogen levels

ROTEM might help guiding fibrinogen transfusion during PPH

Influence of point of care testing (POCT)

INR 1.45, PTT 68,4 sec, Fibrinogen 0.6 g/l, Platelets 114 G/l

CD for a Placenta Preavia patient suffers severe PPH (blood loss ≈ 2000 ml)

Patient already received: 3 PRBCs, 3 FFPs, 4g Fibrinogen, 1g of tranexamic acid

ROTEM® at the time of arrival in the radiology suite

Failure of embolization – HysterectomyROTEM® at the time of arrival in ICU after

Patient received a total of: 18 PRBCs, 17 FFPs, 1 PC, 13g Fibrinogen, 1g tranexamicacid, 2400 UI of PCC, Novoseven 7mg

INR 1, PTT 37,45sec, Fibrinogen 1.7 g/l, Platelets 51 G/l

Plan





• Conclusions

Level of evidence supporting the use of fibrinogen concentrate in severe PPH

• Low fibrinogen level is a marker associated with severe PPHCharbit B et al. J Thromb Haemost 2007; 5: 593-8

• Retrospective studies and case series support its use in addition to conventional treatment

Bell et al. IJOA 2010; 19:218-23

Fenger-Eriksen C et al. BJA 2008Glover et al. Anaesthesia 2010; 65: 1229-30Bonnet et al. EJOGRB 2011, 158. 183-8

• Large RCT prospective studies are acutely needed !

PPV = 100 % when fibrinogen < 2.0 g/lNPP = 79% when fibrinogen > 4.0 g/l

• RCT 249 patients with PPH

• Early empirical administration of 2 g of fibrinogen concentrate

• Outcome: blood transfusion

• The main result of Wikkelsø study is the lack of benefit of fibrinogen administration during early PPH in patients with normal fibrinogen level

• Only 2.2% of the patients had a level of fibrinogen < 2 g/l

• The most relevant population may not have been included (46 patients not enrolled because of severe bleeding and no time to obtain consent)

Editorial

Prospective two-phase study

Phase 1: Shock Pack Group (n=42)

Phase 2: Fibrinogen Group (n=51)

Decrease in blood component therapy

Mallaiah et al. Anaesthesia 2015: 70; 166–175

Ongoing controversies regarding the use of fibrinogen concentrate in severe PPH

• Should fibrinogen be given only when a decrease in plasma is measured?

• What is the appropriate fibrinogen level for replacement in pregnancy?

• What is the dosage of fibrinogen concentrates?

• What is the benefit of a goal-directed approach using POCT ?

• Large RCT prospective studies are acutely needed !

Ickx & Samama BJA 2015

Plan





• Conclusions

TXA for prevention of PPH following CD

Two systematic reviews and meta-analysis (9-10 trials included)

Prophylactic TXA at CD decreases :– postpartum blood loss; MWD = 136 ml !

– PPH

– need for additional uterotonic agents

– hemoglobin drop, and need for blood transfusion

But:

Many studies of poor methodological qualities

Lack of power to assess maternal adverse effects (appears to be safe)

Lack of data on neonatal effects of TXA (appears to be safe)

Sentilhes et al. British Journal of Anaesthesia 2015; 114 (4): 576–87

Simonazzi et al. Acta Obstet Gynecol Scand 2016; 95:28–37

TXA for the prevention of PPH following vaginal deliveries

Two RCT

Infusion of 1g of TXA at delivery following VD decreases:– postpartum blood loss by ≈ 90 ml !

But:

Relatively small studies

Methodological issues

Lack of power to assess maternal adverse effects (appears to be safe)

Yang et al. Zhonghua Fu Chan Ke Za Zhi 2001; 36: 590–2

Gungorduk et al. Am J Perinatol 2013; 30: 407–13

TXA in the treatment of PPH

One small RCT (144 patients):

Administration of high doses TXA (4g + 1g/h q6h) in PPH after VD reduces:

– blood loss (median reduction ≈ 50 ml)

– duration of bleeding

– maternal morbidity

Awaiting further evidence :

• “WOMAN Trial” 20’000 patients mostly in emerging countries, study the effect of TXA to treat PPH (awaiting results).

• “TRAPP Study” 4000 patients in France will study the effect of prophylactic TXA administration for vaginal delivery.

Sentilhes et al. BMC Pregnancy and Childbirth 2015; 15:135

Shakur H et al. Woman Trial. Trials 2010: 11: 40

Ducloy-Bouthors et al. Critical Care 2011, 15: R117

Factor VIIa (Novoseven®) for severe PPH

• Level of evidence: case reports / case series / registries

• One French multicentric RCT

Reduce the need for invasive therapy (RR 0.56; NNT ≈ 3)

Increased risk of thrombosis (NNH ≈ 20)Lavigne-Lissalde et al.J Thromb Haemost. 2015

Factor VIIa may be considered as a “last ditch” therapy :

• Only after optimization of T°, pH, calcemia, fibrinogen, platelets

• Before peripartum hysterectomy

• Dose 90 mcg/kg (systematic review: median 81.5 mcg/kg)

• Effective in reducing bleeding in 85 % of cases

Adverse events: 2.5-5 % of thromboembolic complications

Mercier et Bonnet. Current Opinion Ananesthesiol 2010 (23); 310-16

Franchini et al. Clin Obst Gynecol 2010; 53: 219-27

Huber AW et al. J Perinat Med 2012; 40: 43-9

Conclusions

• PPH remains the “biggest killer” of mothers worldwide !

• Implement “obstetric hemorrhage safety bundle”

– Readiness (Every Unit)

– Recognition and Prevention (Every Patient)

– Response (Every Hemorrhage)

– Reporting and Systems Learning (Every Unit)

• Coagulation and blood management strategies are evolving

• Point of care coagulation testing is useful to manage PPH

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