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The SMI Hemorrhage Bundle: The 4 R’s
Cynthia Chazotte, MD, FACOGCo‐Chair, Safe Motherhood Initiative
Professor EmeritaAlbert Einstein College of Medicine/Montefiore Medical Center
Objectives• To recognize the stages of hemorrhage and respond appropriately
• To understand the need for patient, family and staff support after a hemorrhage
• I have/I don’t have financial interest or other relationships with the industry relative to the topics being discussed.
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ACOG DISTRICT II’S
THE SAFE MOTHERHOOD INITIATIVEMaternal Safety BundlesReducing the rate of maternal mortality and morbidity in New York State
• Implementation of standardized care management plans for 3 leading causes of maternal mortality & morbidity: • Hemorrhage• Severe hypertension• Venous thromboembolism
• Currently in 94% of obstetric hospitals in New York State (117 out of 124)
Maternal Safety Bundle for Obstetric Hemorrhage
REVISED NOVEMBER 2015
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Disclaimer: The following material is an example only and not meant to be prescriptive. ACOG accepts no liability for the content or for the consequences of any actions taken on the basis of the information provided.
OBSTETRIC HEMORRHAGE: KEY ELEMENTSThe 4 R’s
• RECOGNITION & PREVENTION
(every patient)
• Risk assessment
• Universal active management of 3rd stage of labor
• READINESS (every unit)
• Blood bank (massive transfusion protocol)
• Cart & medication kit
• Hemorrhage team with education & drills for all stakeholders
• RESPONSE (every hemorrhage)
• Checklist
• Support for patients/families/staff for all significant hemorrhages
• REPORTING / SYSTEMS LEARNING (every unit)
• Culture of huddles & debrief
• Multidisciplinary review of serious hemorrhages
• Monitor outcomes & processes metrics
EXAMPLE3
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Case – Prenatal History
48 y/o G4 P0030 at 36w6d with IVF twins admitted for delivery planning.Issues:• Monochorionic/diamniotic with fetal growth restriction of
twin B • History of ITP – Platelet count of 30,000 on prednisone for
3 days prior• Rh negative• Class 1 Obesity• Prior myomectomy• 3 1st trimester spontaneous Ab’s, 2 with D&C’s• Admission platelet count 48,000, Hematocrit 38%
Recognition:
Prenatal Risk Assessment
This patient is at risk for accreta because
a) Multiple gestation
b) Class 1 obesity
c) Prior myomectomy
d) History of ITP
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Imaging
Ultrasound findings: Anterior placenta, no mention of findings suggestive of accreta.
Does she need an MRI?
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Recognition:
Prenatal Risk Assessment
Are there other prenatal risks for hemorrhage?
Does she need transfer to higher level of care?
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Recognition:
Prenatal Risk Assessment• Suspected previa/accreta/increta/percreta*
• Pre‐pregnancy BMI >50
• Clinically significant bleeding disorder
• Other significant medical/surgical risk (consider patients who decline transfusion)***
Transfer to appropriate level of care for delivery ***
* See supplemental guidance document on morbidly adherent placenta
** See supplemental guidance document on patients who decline blood products
*** Review availability of medical/surgical, blood bank, ICU, and interventional radiology support
EXAMPLE4
Recognition:RISK ASSESSMENT: LABOR & DELIVERY ADMISSION
Medium Risk
[ ] Prior cesarean, uterine surgery,
or multiple laparotomies
[ ] Multiple gestation
[ ] >4 prior births
[ ] Prior obstetric hemorrhage
[ ] Large myomas
[ ] EFW >4000 g
[ ] Obesity (BMI >40)
[ ] Hematocrit <30% & other risk
Type & SCREEN, review protocol
High Risk
[ ] Placenta previa/low lying
[ ] Suspected accreta/percreta
[ ] Platelet count <70,000
[ ] Active bleeding
[ ] Known coagulopathy
[ ] 2 or more medium risk factors
Type & CROSS, review protocol * Establish a culture of huddles for high‐risk patients & post‐event debriefing *
EXAMPLE6
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RISK ASSESSMENT: INTRAPARTUM
Medium Risk
[ ] Chorioamnionitis[ ] Prolonged oxytocin >24 hours[ ] Prolonged 2nd stage[ ] Magnesium sulfate
Type & SCREEN, review protocol
High Risk
[ ] New active bleeding[ ] 2 or more medium risk factors
(admission &/or intrapartum)
* Establish a culture of huddles for high‐risk patients & post‐event debriefing *
Type & CROSS, review protocol
EXAMPLE7
Readiness:BLOOD BANK: MASSIVE TRANSFUSION PROTOCOL
1.In order to provide safe obstetric care institutions must:
• Have a functioning Massive Transfusion Protocol (MTP)
• Have a functioning Emergency Release Protocol (a minimum of 4 units of O‐negative/uncrossmatched RBCs)*
• Have the ability to obtain 6 units PRBCs and 4 units FFP (compatible or type specific) for a bleeding patient
• Have a mechanism in place to obtain platelets and additional products in a timely fashion
Blood transfusion or crossmatching should not be used as a negative quality marker &is warranted for certain obstetric events.
EXAMPLE10
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STATEMENT ON THE USE OF BLOOD PRODUCTS
Blood transfusion or crossmatching should not be used as a negative quality marker and is warranted for certain obstetric events. In cases of severe obstetric hemorrhage, ≥4 units of blood products may be necessary to save the life of a maternity patient.
Hospitals are encouraged to coordinate efforts with their laboratories, blood banks, and quality improvement departments to determine the appropriateness of transfusion and quantity of blood products necessary for these patients.
EXAMPLE11
Readiness:BLOOD BANK: MASSIVE TRANSFUSION PROTOCOL
Important protocol items to be determined at each institution are:
1. How to activate MTP
2. Blood bank number & location; notify as soon as possible
3. Emergency release protocol that both blood bank staff and ordering parties (MD/RN/CNM) understand
4. How will blood be brought to L&D?
5. How will additional blood products/platelets be obtained?
6. Mechanism for obtaining serial labs, such as with each transfusion pack, to ensure transfusion targets achieved
EXAMPLE12
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Readiness:RECOMMENDED INSTRUMENTS
HEMORRHAGE CARTVaginal
[ ] Vaginal retractors; long weighted speculum
[ ] Long instruments (needle holder, scissors, Kelly clamps, sponge forceps)
[ ] Intrauterine balloon
[ ] Banjo curette
[ ] Bright task light
[ ] Procedural instructions (balloon)
Cesarean/Laparotomy
[ ] Hysterectomy tray
[ ] #1 chromic or plain catgut suture & reloadable straight needle for B‐Lynch sutures
[ ] Intrauterine balloon
[ ] Procedural instructions(balloon, B‐Lynch, arterialligations)
EXAMPLE15
RECOMMENDED MEDICATION KIT(for rapid access to medications)
[ ] Oxytocin (Pitocin) 10‐40 units per 500‐1000mL solution 2 pre‐mixed bags
[ ] Oxytocin (Pitocin) 10 units 2 vials
[ ] 15‐methyl PGF2α (Hemabate) 250 micrograms/milliliters 1 ampule *
[ ] Misoprostol (Cytotec) 200 microgram tablets 5 tabs
[ ] Methylergonovine (Methergine)0.2 milligrams/milliliters 1 ampule *
* Needs refrigeration
EXAMPLE16
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Other Medications
• Tranexamic acid– Anti‐fibrinolytic drug
– Not standard therapy for PPH
– Has been used in “severe PPH”
– 4gm in 50ml NS over 1 hour followed by 1g/hr for six hours
• Recombinant Factor VIIa– Usual use factor deficiencies
– Off label use for intractable PPH
– 40 or 60 mcg/kg bolus, can repeat once in 15‐30 minutes
– Risk for thromboses
Other Medications
• Fibrinogen concentrate (RiaSTAP) – Heat treated, fibrinogen powder from pooled plasma– Contains 900‐1300mg fibrinogen & 400‐700mg human albumin– Used if fibrinogen levels critically low (<100mg/dl)– Does not need thawing and can be used with cryo
• Prothrombin complex concentrate – 3 factor (II, IX, X) and four factor (II, VII, IX, X) prothrombin complex
concentrates (PCC) – Possible alternative to FFP– Advantages: reduced risk of volume overload, no need for thawing or
blood group typing, and a reduced risk for transfusion‐related acute lung injury and allergic reactions.
– Disadvantages: very high cost and increased risk of thrombosis.
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Delivery
• Uneventful primary cesarean delivery under general anesthesia with EBL 1000cc– A 2510gm Apgars 5/8
– B 1720gm Apgars 6/9
• VS 137/79, pulse 75 at conclusion of case.
• What stage of Hemorrhage?
PACU – 1 hr PP
• VS: pulse 96, BP 108/62
• Gush of vaginal blood. Uterus atonic.
• Oxytocin was not running.
• Oxytocin (30U/500cc) IV, Cytotec 1000mcg PR
• 1000cc clot evacuated in PACU
What stage of Hemorrhage?
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Recognition & Response: What Stage of Hemorrhage?
a) Stage 0
b) Stage 1
c) Stage 2
d) Stage 3
e) Stage 4
RECOGNITION
Call for assistance (obstetric hemorrhage team)
Designate
Team leader
Checklist reader/recorder
Primary RN
Announce
Cumulative blood loss
Vital signs
Determine stage
Recognition & Response:HEMORRHAGE CHECKLIST
Complete all steps in prior stage plus current stage regardless of stage in which patient presents.
EXAMPLE17
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Recognition & Response:CHECKLIST: STAGE 1
Blood loss >500 mL vaginal OR blood loss >1000 mL cesareanWITH NORMAL VITAL SIGNS and LAB VALUES
INITIAL STEPS
Ensure 16G or 18G IV access
Increase IV fluid (crystalloid without oxytocin)
Insert indwelling urinary catheter
Fundal massage
MEDICATIONS
Increase oxytocin, additional uterotonics
BLOOD BANK
Type & crossmatch 2 units RBCs
ACTION
Determine etiology & treat
Prepare OR, if clinically indicated
(optimize visualization/examination)
Oxytocin (Pitocin)10‐40 units per 500‐1000mL solution
Methylergonovine (Methergine)0.2 milligrams IM (may repeat)
15‐methyl PGF2α (Hemabate, Carboprost)250 micrograms IM (may repeat in q15minutes, maximum 8 doses)
Misoprostol (Cytotec)800‐1000 micrograms PR600 micrograms PO or 800 micrograms PL
Tone (i.e., atony) Trauma (i.e., laceration) Tissue (i.e., retained products)Thrombin (i.e., coagulation dysfunction)
EXAMPLE18
CHECKLIST: STAGE 2Continued bleeding EBL up to 1500 mL OR
>2 uterotonics WITH NORMAL VITAL SIGNS and LAB VALUES
INITIAL STEPS
Mobilize additional help
Place 2nd IV (16‐18G)
Draw STAT labs (CBC, coags, fibrinogen)
Prepare OR
MEDICATIONS
Continue Stage 1 medications
BLOOD BANK
Obtain 2 units RBCs (DO NOT wait for labs. Transfuse per clinical signs/symptoms)
Thaw 2 units FFP
ACTION
Escalate therapy with goal of hemostasis
Huddle and move to Stage 3 if continued blood loss and/or abnormal VS
EXAMPLE19
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CHECKLIST: STAGE 3Continued bleeding with EBL >1500 mL OR >2 units RBCs given
OR Patient at risk for occult bleeding/coagulopathy OR any patient with abnormal vital signs/labs/oliguria
INITIAL STEPS
Mobilize additional help
Move to OR
Announce clinical status
(vital signs, cumulative blood loss, etiology)
Outline & communicate plan
MEDICATIONS
Continue Stage 1 medications
BLOOD BANK
Initiate massive transfusion protocol
(If clinical coagulopathy: add cryoprecipitate, consult for additional agents)
ACTION
Achieve hemostasis, interventions based on etiology
Oxytocin (Pitocin)10‐40 units per 500‐1000mL solution
Methylergonovine (Methergine)0.2 milligrams IM (may repeat)
15‐methyl PGF2α (Hemabate, Carboprost)250 micrograms IM (may repeat in q15minutes, maximum 8 doses)
Misoprostol (Cytotec)800‐1000 micrograms PR600 micrograms PO or 800 micrograms PL
EXAMPLE23
CHECKLIST: STAGE 4Cardiovascular Collapse (massive hemorrhage, profound hypovolemic shock or
amniotic fluid embolism)
INITIAL STEPS
Mobilize additional resources
MEDICATIONS
ACLS
BLOOD BANK
Simultaneous aggressive massive transfusion
ACTION
Immediate surgical intervention to ensure hemostasis (hysterectomy)
EXAMPLE24
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Return to OR – 2.5 hrs PP
• Lower uterine segment atony persists• Exam under anesthesia, manual evacuation of clots, Bakri placement under ultrasound guidance
• Hemabate X 3• MTP activated• EBL: 1000cc clot prior OR evaluation & 1000cc in OR• Fluids:
– 1000 mL LR– 2U PRBC– 2U FFP– 1U plt
CHECKLIST: STAGE 3Continued bleeding with EBL >1500 mL OR >2 units RBCs given
OR Patient at risk for occult bleeding/coagulopathy OR any patient with abnormal vital signs/labs/oliguria
INITIAL STEPS
Mobilize additional help Move to OR Announce clinical status NO
(vital signs, cumulative blood loss, etiology)
Outline & communicate plan MEDICATIONS
Continue Stage 1 medications BLOOD BANK
Initiate massive transfusion protocol (If clinical coagulopathy: add cryoprecipitate, consult for additional agents)
ACTION
Achieve hemostasis, interventions based on etiology NOT YET
Oxytocin (Pitocin)10‐40 units per 500‐1000mL solution
Methylergonovine (Methergine)0.2 milligrams IM (may repeat)
15‐methyl PGF2α (Hemabate, Carboprost)250 micrograms IM (may repeat in q15minutes, maximum 8 doses)
Misoprostol (Cytotec)800‐1000 micrograms PR600 micrograms PO or 800 micrograms PL
EXAMPLE23
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Delivery Day‐ Back to PCAU ‐3.5hr PP
Pt reports feeling wet in her bottom. Denies SOB/dizziness/CP.• T98.2, 100/78, 85, 18• 2 IV lines in place• Abdomen: nondistended• BSUS: Thin ES from fundus to mid‐uterus. No clots noted superior to Bakri• Bakri: in place, 200cc noted • Foley: 1200cc. • Labs: Hct 26, Plt 43, Fib 116• Total Transfusion• 4U PRBC (960cc)• 2U FFP (500cc)• 1U Plt (50cc)
What stage of hemorrhage?
POD #1 – 20.5 hrs PP
• To Interventional Radiology
• Post partum uterine atony & persistent bleeding despite endometrial tamponade balloon deployment
• Bilateral uterine artery embolization (UAE)
• To ICU
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Postpartum course
• POD1: scant bleeding after UAE
• POD2: Bakri removed (40 hrs PP)
• POD3: Platelet count 33,000
• Total Blood products:
– 11 PRBC’s, 4 FFP, 6 cryo, 5 platelets
• POD3‐6: Corticosteroid, IVIG
• POD7: Discharge home Hct 23.6%,plt ct 147,000
• 2 month PP Hct 38.6%, plt ct 184,000
Response: CHECKLIST: POST‐HEMORRHAGE MANAGEMENT
Determine disposition of patient (whether ICU required)
Debrief with the whole obstetric care team
Debrief with patient and family multiple times
Document
EXAMPLE25
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REPORTING / SYSTEMS LEARNING(every unit)
• Establish a culture of huddles for high‐risk patients and post‐event debriefs
• Conduct a multidisciplinary review of serious hemorrhages for systems issues
• Monitor outcomes and processes metrics
EXAMPLE26
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THANK YOU
https://safehealthcareforeverywoman.org/patient‐safety‐bundles/support‐after‐a‐severe‐maternal‐event‐supported‐by‐aim/
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CONCLUSION
• Early opportunities exist to assess risk, anticipate, and plan in advance of an obstetric hemorrhage.
• Multidisciplinary coordination and preparation, particularly with the blood bank, is critical in order to provide safe obstetrical care.
• A standardized approach to obstetric hemorrhage includes a clearly defined, staged checklist of appropriate actions to be taken in an emergency situation and can help to improve patient outcomes.
• Support for patient and family very important
EXAMPLE27
District II Delivers… Its SMI App
• Turn on your mobile device
• Go to the App Store or Google Play
• Search ACOG District II
• Download for FREE
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The American College of Obstetricians and Gynecologists. “Postpartum Hemorrhage.” Practice Bulletin, Number 76. October 2006.
The American College of Obstetricians and Gynecologists. “Placenta Accreta.” Committee Opinion, Number 529. July 2012. http://tinyurl.com/pf3rweu
The American College of Obstetricians and Gynecologists. “Postpartum Hemorrhage from Vaginal Delivery.” Patient Safety Checklist, Number 10. May 2013. http://tinyurl.com/kltnspw
Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN). Postpartum Hemorrhage Project: A Multi‐Hospital Quality Improvement Program, 2013. http://www.pphproject.org
Campbell KH, Savitz D, Werner EF, et al. “Maternal morbidity and risk of death at delivery hospitalization.” Obstetrics and Gynecology, 2013(122): pp. 627‐33.
Chen M, Chang Q, Duan T, et al. “Uterine massage to reduce blood loss after vaginal delivery.” Obstetrics and Gynecology, 2013(122): pp. 290‐5.
Guly HR, Bouamra, O, Spiers M, et al. “Vital signs and estimated blood loss in patients with major trauma: Testing the validity of the ATLS classification of hypovolaemic shock.” Resuscitation, 2011(82): pp. 556‐9.
Lyndon A, Lagrew D, Shields L, Melsop K, Bingham B, Main E (Eds). “Improving Health Care Response to Obstetric Hemorrhage.” (California Maternal Quality Care Collaborative Toolkit to Transform Maternity Care) Developed under contract #08‐85012 with the California Department of Public Health; Maternal, Child and Adolescent Health Division; Published by the California Maternal Quality Care Collaborative, July 2010. https://cmqcc.org/ob_hemorrhage
Mutschler M, Nienaber U, Brockamp T, et al. “A critical reappraisal of the ATLS classification of hypovolaemic shock: Does it really reflect clinical reality?” Resuscitation, 2013(84): pp. 309‐13.
Parks JK, Elliott, AC, Gentilello LM, Shafi S. “Systemic hypotension is a late marker of shock after trauma: a validation study of Advanced Trauma Life Support principles in a large national sample.” The American Journal of Surgery, 2006(192): pp. 727‐31.
References