1

Massive Obstetric Hemorrhage Trauma Blood Replacement Strategies

and Algorithms to Prevent the

“Lethal Triad” of Non-Survivors "

Carol J Harvey, MS, RNC-OB, C-EFM"Clinical Specialist"

Women�s Services"Northside Hospital"Atlanta, Georgia"

March 12, 2010

CDC’s Pregnancy Mortality Surveillance System

h!p://www.cdc.gov/reproductivehealth/MaternalInfantHealth/PMSS.html#5

ACOG Practice Bulletin #76, Oct 2006!!  �Although many risk factors

have been associated with postpartum hemorrhage, it often occurs without warning.�!

!  �All obstetric units and practitioners must have the facilities, personnel, and equipment in place to manage this emergency properly.�!

Joint Commission Sentinel Event Alert: Issue 44, January 26, 2010

Reported Errors in Management of Postpartum Hemorrhage

!  Failure to accurately measure blood loss

!  Delay in identifying hemorrhage

!  Delay in ordering blood

!  Delay in starting blood transfusions

!  Delay in moving patient to an operating room

!  Delay in getting assistance

!  Delay in acquiring hemostasis

!  Failure to identify and/or manage shock Harvey, Dildy. (2012) Massive Postpartum

Hemorrhage. (chpt.) in Troiano, Harvey, Chez, …!

2

Reported Errors in Management of Postpartum Hemorrhage

!  Failure to accurately measure blood loss

!  Delay in identifying hemorrhage

!  Delay in ordering blood

!  Delay in starting blood transfusions

!  Delay in moving patient to an operating room

!  Delay in getting assistance

!  Delay in acquiring hemostasis

!  Failure to identify and/or manage shock Harvey, Dildy. (2012) Massive Postpartum

Hemorrhage. (chpt.) in Troiano, Harvey, Chez, …!

Collaboratively create clinical guidelines that “standardize” the circumstances under which an order or action are initiated.

Transfer of Patient to an OR: Algorithm Sign Management Action

Patient is bleeding after delivery; uterine atony

Bimanual compression (PCP), uterine massage, oxytocin (IV-diluted, or IM)

Monitor patient: VS every 15 minutes, delivery provider remains at BS, etc.

Bleeding continues 2nd line Uterotonic (any) ordered

Monitor patient, notify charge person, provider at BS.

Bleeding continues 3rd line Uterotonic (any) ordered, or – a second dose of the 2nd line uterotonic

Charge nurse notified, anesthesia notified, delivering MD or MD backup to BS, transfer patient to an OR.

Evidence-based MTP and Guidelines/Protocols

Transfer of Patient to OR (cont’)"!  More than one uterotonic (in addition to oxytocin) is

employed, or more than one dose of a uterotonic is administered;"

!  Retractors or assistance is required to visualize the vagina;"

!  Blood products become necessary (excluding blood transfusions for the sole purpose of increase H&H in a stable patient); or"

!  Hemodynamic instability (tachycardia or hypotension unrelated to epidural analgesia/anesthesia)."

http://www.cmqcc.org/ob_hemorrhage �

Management of OB

Hemorrhage

!

!

California Maternal Quality Care Collaborative (CMQCC): Hemorrhage Taskforce (2009) visit: www.CMQCC.org for details This Project was supported by Title V funds received from the State of California, Department of Public Health, Center for Family Health; Maternal, Child and Adolescent Health Division

Obstetric Hemorrhage Care Summary: Table Chart Format version 1.4

Assessments Meds/Procedures Blood Bank

Stage 0 Every woman in labor/giving birth

Stage 0 focuses on risk assessment and active management of the third stage.

• Assess every woman for risk factors for hemorrhage

• Ongoing quantitative evaluation of blood loss on every birth

Active Management 3rd Stage:

• Oxytocin IV infusion or 10u IM

• Fundal Massage-vigorous, 15 seconds min.

• If Medium Risk:T&Scr • If High Risk: T&C 2 U • If Positive Antibody

Screen (prenatal or current, exclude low level anti-D from RhoGam):T&C 2 U

Stage 1 Blood loss: >500 ml vaginal or >1000 ml Cesarean, or VS changes (by >15% or HR !110, BP "85/45, O2 sat <95%)

Stage 1 is short: activate hemorrhage protocol, initiate preparations and give Methergine IM.

• Activate OB Hemorrhage Protocol and Checklist

• Notify Charge nurse, Anesthesia Provider

• VS, O2 Sat q5’ • Calculate cumulative

blood loss q5-15’ • Weigh bloody materials • Careful inspection with

good exposure of vaginal walls, cervix, uterine cavity, placenta

• IV Access: at least 18gauge • Increase IV fluid (LR) and

Oxytocin rate, and repeat fundal massage

• Methergine 0.2mg IM (if not hypertensive) May repeat if good response to first dose, BUT otherwise move on to 2nd level uterotonic drug (see below)

• Empty bladder: straight cath or place foley with urimeter

• T&C 2 Units PRBCs (if not already done)

Stage 2 Continued bleeding with total blood loss under 1500ml

Stage 2 is focused on sequentially advancing through medications and procedures, mobilizing help and Blood Bank support, and keeping ahead with volume and blood products.

OB back to bedside (if not already there) • Extra help: 2nd OB,

Rapid Response Team (per hospital), assign roles • VS & cumulative blood

loss q 5-10 min • Weigh bloody materials • Complete evaluation

of vaginal wall, cervix, placenta, uterine cavity • Send additional labs,

including DIC panel • If in Postpartum: Move

to L&D/OR • Evaluate for special

cases: -Uterine Inversion -Amn. Fluid Embolism

2nd Level Uterotonic Drugs: • Hemabate 250 mcg IM or • Misoprostol 800-1000 mcg

PR

2nd IV Access (at least 18gauge)

Bimanual massage Vaginal Birth: (typical order) • Move to OR • Repair any tears • D&C: r/o retained placenta • Place intrauterine balloon • Selective Embolization

(Interventional Radiology) Cesarean Birth: (still intra-op) (typical order) • Inspect broad lig, posterior

uterus and retained placenta

• B-Lynch Suture • Place intrauterine balloon

• Notify Blood Bank of OB Hemorrhage

• Bring 2 Units PRBCs to bedside, transfuse per clinical signs – do not wait for lab values • Use blood warmer for transfusion • Consider thawing 2 FFP (takes 35+min), use if transfusing >2u PRBCs

• Determine availability of additional RBCs and other Coag products

Stage 3 Total blood loss over 1500ml, or >2 units PRBCs given or VS unstable or suspicion of DIC

Stage 3 is focused on the Massive Transfusion protocol and invasive surgical approaches for control of bleeding.

• Mobilize team -Advanced GYN surgeon -2nd Anesthesia Provider -OR staff -Adult Intensivist • Repeat labs including

coags and ABG’s • Central line • Social Worker/ family

support

• Activate Massive Hemorrhage Protocol • Laparotomy: -B-Lynch Suture -Uterine Artery Ligation -Hysterectomy • Patient support -Fluid warmer -Upper body warming device -Sequential compression stockings

Transfuse Aggressively Massive Hemorrhage Pack • Near 1:1 PRBC:FFP • 1 PLT pheresis pack per 6units PRBCs

Unresponsive Coagulopathy: After 10 units PRBCs and full coagulation factor replacement: may consider rFactor VIIa

3

PPH - Blood Transfusions

Blood Loss:

1000-1500 ml

Stage 2

Sequentially

Advance through

Medications &

Procedures

Pre-

Admission

Time of

admission

Identify patients with special consideration:

Placenta previa/accreta, Bleeding disorder, or

those who decline blood products

Follow appropriate workups, planning, preparing of

resources, counseling and notification

Screen All Admissions for hemorrhage risk:

Low Risk, Medium Risk and High Risk

Low Risk: Hold clot

Medium Risk: Type & Screen, Review Hemorrhage Protocol

High Risk: Type & Crossmatch 2 Units PRBCs; Review Hemorrhage

Protocol

All women receive active management of 3rd stage

Oxytocin IV infusion or 10 Units IM

Vigorous fundal massage for 15 seconds minimum

Standard Postpartum

Management

Fundal Massage

Vaginal Birth:

Bimanual Fundal Massage

Retained POC: Dilation and Curettage

Lower segment/Implantation site/Atony: Intrauterine Balloon

Laceration/Hematoma: Packing, Repair as Required

Consider IR (if available & adequate experience)

Cesarean Birth:

Continued Atony: B-Lynch Suture/Intrauterine Balloon

Continued Hemorrhage: Uterine Artery Ligation

To OR (if not there);

Activate Massive Hemorrhage Protocol

Mobilize Massive Hemorrhage Team

TRANSFUSE AGGRESSIVELY

RBC:FFP:Plts ! 6:4:1 or 4:4:1

Increased

Postpartum

Surveillance

Definitive Surgery

Hysterectomy

Conservative Surgery

B-Lynch Suture/Intrauterine Balloon

Uterine Artery Ligation

Hypogastric Ligation (experienced surgeon only)

Consider IR (if available & adequate experience)

Fertility Strongly Desired

Consider ICU

Care; Increased

Postpartum

Surveillance

Verify Type & Screen on prenatal

record;

if positive antibody screen on prenatal

or current labs (except low level anti-D

from Rhogam), Type & Crossmatch 2

Units PBRCs

CALL FOR EXTRA HELP

Give Meds: Hemabate 250 mcg IM -or-

Misoprostol 800-1000 mcg PR

Cumulative Blood Loss>500 ml Vag; >1000 ml CS

>15% Vital Sign change -or-

HR !110, "#$%85/45

O2 Sat <95%, Clinical Sx

Ongoing

Evaluation:

Quantification of

blood loss and

vital signs

Unresponsive Coagulopathy:

After 10 Units PBRCs and full

coagulation factor replacement,

may consider rFactor VIIa

HEMORRHAGE CONTINUES

Blood Loss:

>1500 ml

Stage 3

Activate

Massive

Hemorrhage

Protocol

Blood Loss:

>500 ml Vaginal

>1000 ml CS

Stage 1Activate

Hemorrhage

Protocol

NO

Stage 0

All Births

Transfuse 2 Units PRBCs per clinical

signs

Do not wait for lab values

Consider thawing 2 Units FFP

YES

YES NO

Ongoin

g C

um

ula

tive B

lood

Lo

ss E

va

luation

Cumulative Blood Loss

>1500 ml, 2 Units Given,

Vital Signs Unstable

YESIncrease IV rate (LR); Increase Oxytocin

Methergine 0.2 mg IM (if not hypertensive)

Continue Fundal massage; Empty Bladder; Keep Warm

Administer O2 to maintain Sat >95%

Rule out retained POC, laceration or hematoma

Order Type & Crossmatch 2 Units PRBCs if not already done

Activate Hemorrhage Protocol

CALL FOR EXTRA HELP

Continued heavy

bleeding

Increased

Postpartum

Surveillance

NO

NO

CONTROLLED

INCREASED BLEEDING

California Maternal Quality Care Collaborative (CMQCC), Hemorrhage Taskforce (2009) visit: www.CMQCC.org for details

This project was supported by Title V funds received from the State of California Department of Public Health, Center for Family Health; Maternal, Child and Adolescent Health Division

OBSTETRIC HEMORRHAGE CARE SUMMARY: FLOW CHART FORMAT v 1.4 4/5/2010

www.CMQCC.org AWHONN OB Hemorrhage

h!p://www.awhonn.org/awhonn/store/productDetail.do;jsessionid=17C3132EB99F9

E0BDE7E225573E08107?productCode=OH-312

PPH - Blood Transfusions

Algorithm for Management of PPH.

From: Harvey, Dildy (2012) Massive Postpartum Hemorrhage, in Troiano, Harvey & Chez AWHONN�s High Risk and Critical Care Obstetrics, 3rd Edition, Lippinco!, Williams & Wilkins: Philadelphia.

h!p://www.acog.org/About_ACOG/ACOG_Districts/District_II/~/media/Districts/District%20II/PDFs/Final_Hemorrhage_Web.pdf

Measuring Blood Loss

!  Visual estimation

!  Indirect measurement !  Direct measurement

Visual'comparisons:''Lap'sponges'

25#ml#######50#ml#########75#ml#######100#ml#

Mini#Lap'###4#in.#x#18#in.##

##'''''''''

25#ml###########50#ml#

18#x#18#inch#dry#lap#sponge##

CMQCC

4

Measuring Blood Loss

Mölnlycke Health Care AB, Box 13080, SE-402 52 Göteborg, Sweden, Phone: +46 31 722 30 00, Fax: +46 31 722 34 01, www.molnlycke.comThe Mölnlycke Health Care name and logo and ProcedurePak® are registered trademarks of Mölnlycke Health Care AB.

1 2 3

4 5

Description Colour

This product is only available as a component in our minor procedure trays and kits.

CMQCC

What is the most accurate method to determine estimated blood loss at delivery, c-section or surgery?

The Answer:

! Weigh all linen, waste ! Measure amounts in containers ! Subtract out estimates for amniotic fluid, irrigation, urine

! Record total

New Guidelines for Blood Transfusions

PPH - Blood Transfusions

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!  Coagulopathy present on admission in severe injuries (10 – 25%)

!  Most mortality from this group

!  Early coagulopathy WITHOUT hemodilution; prior to hypothermia and/or acidosis

!  Evidence of cell based vs. strict coagulation cascade for hemostasis

Dawes, 2009

Hemorrhage Research in Afghanistan and Iraq

Hemorrhage resuscitation: What�s New - ! Crystaloids (avoid colloids ?) ! Early transfusion of FFP ! Early transfusion of PRBC ! Early transfusion of platelets

! Ratio: FFP:PRBC:PLT = 1:1:1 (or near 1:1:1)

! Early prevent/ID/tx �Deadly Triad�

1:1:1 ratios of FFP : Platelets : PRBCs -decrease mortality in massive transfusion of trauma patients

Ma!hew A Borgman, MD

U.S. Civilian Trauma Centers Review

!  16 centers, 467 patients !  Excluded deaths within 30 min !  4 groups based on 1:2 ratio cut-off of plasma

or plt to RBCs: 24-hr Survival !  High plasma, high platelets 87% !  High plasma, low platelets 86% !  Low plasma, high platelets 83% !  Low plasma, low platelets 58%

Holcomb, et al. �Increased plasma and platelets to RBC ratios improves outcome in 466 massively Transfused Civilian Trauma patients.� Annals of Surgery. 248 (3) 2008. 447-458

Ma!hew A Borgman, MD

OB Hemorrhage Pack MTP'Example'1'

Per Cooler: ! 8 PRBC ! 8 FFP ! 3 platelet

apheresis - (35K - 50K in each)

! 2 adult dose cryo bags (14 - 20 units)

MTP'Example'2'

Per Cooler: ! 6 PRBC ! 6 FFP ! 6 platelet units; or

1-2 apheresis !  (35K - 50K in each)

! 1 adult dose cryoprecipitate

!  (7 – 10 units)

Trauma Exsanguination Protocol (MTP) and Mortality

65.8

51.1

30

35

40

45

50

55

60

65

70

Pre-MTP Post-MTP

Mor

tali

ty (

%)

Co!on, 2008

6

!  Institution's TEP associated with: !  Reduction in multiorgan failure !  Reduction in infectious complications !  Increase in ventilator-free days !  Reduction of abdominal compartment syndrome

�Fresh� PRBCs compared to longer stored PRBCs decrease mortality in massive transfusion of trauma patients

Dawes, Thomas (2009) COCC 15:527-535. ref to Weinberg (2008)

Age of PRBC: Time from donation to transfusion

!  Large retrospective analysis of blood usage in trauma centre

!  Patients that required more than 5 units of blood

!  Pts transfused > 3 units of PRBC !  If older than 14 days - doubled mortality

Dawes, Thomas (2009) COCC 15:527-535. ref to Weinberg (2008)

Transfuse �newest� blood products

“Lethal Triad” of Massive Hemorrhage

and Transfusion

1.  Hypothermia 2.  Acidosis 3.  Coagulopathy

Dawes, 2009

When Triad Present: >65 %

MORTALITY

“Lethal(Triad”((of(Massive(Hemorrhage((

1.  Hypothermia(2.  Acidosis((3.  Coagulopathy(

Dawes, 2009

•  Perpetuating combination of acute coagulopathy, hypothermia, and acidosis seen in exsanguinating trauma patients.

•  Hypo-perfusion leads to:

•  decreased oxygen delivery, a •  switch to anaerobic metabolism, •  lactate production, and •  metabolic acidosis

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Perioperative Hypothermia (PH)

!  The U.S. Center for Disease Control and Prevention (CDC) identified hypothermia as the cause of approx. 600 deaths in the U.S.

(Holtzclaw, 2008, p. 1)

!  A drop in temperature of 2 degrees Celsius increases

blood loss by approx. 500 milliliters. (AORN, 2007, p. 972, 979)

!  One study identified the incidence of culture-positive surgical site infections in patients with mild PH was 3 times higher than normothermic perioperative patients

(Kurz & Sessler, 1996, p. 1214)

Inadvertent perioperative hypothermia

Implementing NICE guidance 2nd.edition August 2011

NICE clinical guideline #65

See the Quick Guide page 4-5 for a guideline. Retrieved at: h!p://guidance.nice.org.uk/CG65/QuickRefGuide/pdf/English

Active Patient Warming Devices Internal Active Patient Warming/Cooling

Less Invasive Procedures for Treatment of Massive Hemorrhage

Secondary to Uterine Atony"

PPH: Success rates of interventions prior to hysterectomy

Doumouchtsis SK, Papageorghiou AT, Arulkumaran S. Systematic review of conservative management of postpartum hemorrhage: what to do when medical treatment fails. Obstet Gynecol Surv 2007; 62: 540-7.

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Intrauterine Tamponade Balloon Catheters

# FDA Approved Catheters: 3

Bakri BT Cath

ebb

Intrauterine Tamponade Balloon Catheters – Maximum Fill Volumes

Bakri 500 mL

B-T Cath 500 mL

ebb Uterine balloon: 750 mL

Relative Size with 1,000 mL IV bag

Bakri BT-Cath ebb

Interventional Radiology

h!p://www3.gehealthcare.com.sg/en-GB/Specialties/Interventional_Radiology

Adjuncts to Transfusion

•  Concentrated fibrinogen •  Activated Recombinant Factor VII

(rFVIIa) •  Antifibinolytics (tranexamic acid)

Recombinant Activated Factor VII:

FDA OFF-LABEL

NovoNordisk -

NovoSeven®

2013 Update

9

Classic Steps- Clotting Cascade XII XIIa

X Xa

XI XIa

IX IXa

VIII VIIIaCa++

Ca++

Tissue thromboplastin (III)

VIIa VII

Prothrombin Thrombin(II) (IIa)

Fibrinogen (I) Fibrin monomers(Ia)

Va V

Thrombin

ProthrombinActivator

Ca++

Ca++

Platelet phospholipids

(Trauma to blood or vessel wall) (Trauma to vessel wall or extravascular tissue)

Fibrin fibers

Cross-linked fibrin fibers

Thrombin activated fibrin stabilizing factor (XIIIa)

Ca++

Diagram courtesy Witcher, TS, DIC (chpt) in AWHONN�s High Risk and CCOB text (in press).

Recombinant Activated FVII?

!  FDA approved for hemophiliacs to treat active bleeding

!  FDA Off-label use as a universal hemostatic agent in various settings of massive blood transfusion

Warnings!

Antifibrinolytics

Antifibinolytics

World Maternal Antifibrinolytic Trial (WOMAN) • Investigators - London School of Hygiene and Tropical Medicine

have begun enrolling patients. • Goal: measure outcomes of women who are given an antifibrinolytic (tranexamic acid) during PPH. • Recruitment goal: 15,000 women who hemorrhage after delivery. • Randomized to either tranexamic acid or placebo. • Follow-up: to 42 days after delivery. • Completion of the study is scheduled for 2015.

Use in PPH is FDA OFF-LABEL!

AWHONN in Leadership Role

•  Improve Recognition •  Improve Readiness •  Improve Response

Summary and Conclusions

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! Thank you, for your time and attention."

Carol J Harvey