2. Deep vein thrombosis
(DVT) forms in a vein of
the leg.
• Characterized by pain,
swelling or tenderness
of the leg, sometimes
with redness and
warmth
Deep Vein Thrombosis
3. Pulmonary Embolism
Pulmonary embolism (PE) occurs when the
blood clot breaks loose and travels to the lungs
• Characterized by shortness of breath, sharp
rib/chest pain and occasionally by
hemoptysis, light-headedness, or collapse
4. Symptoms and Signs of DVT
• Leg pain (90%)
• Tenderness (85%)
• Ankle edema (76%)
• Calf swelling (42%)
• Dilated veins (33%)
• Dusky discoloration
(30%)
• Warmth
• Redness
DVT cannot be reliably
diagnosed on the basis of
history and physical exam, even
in high-risk patients.
Symptomatic DVT
Most hospitalized
patients with DVT
will have NO
SYMPTOMS or SIGNS!
5. Risk of VTE in
Hospitalized Patients
Geerts WT, et al. Chest 2008;358:381S-453S.
Patient Group DVT Prevalence (%)
Medical Patients 10-20
General Surgery 15-40
Major Gynecologic Surgery 15-40
Major Urologic Surgery 15-40
Neurosurgery 15-40
Stroke 20-50
Hip and Knee Arthroplasty,
Hip Fracture Surgery
40-60
Major Trauma 40-80
Spinal Cord Injury 60-80
Critical Care Patients 10-80
6. Pulmonary Embolism
Hospital Risk
•Accounts for 10% of
hospital deaths
•In the UK, PE following
DVT causes between
25,000 and 32,000
deaths each year1
International, cross-
sectional audit of
35,000 inpatients at
risk for VTE found:2
•only 59% of
surgical patients and
40% of medical
patients received
recommended
prophylaxis.
1. UK House of Commons Health Committee. HC 99. Published on 8 March 2005.
2. Cohen AT, et al. Lancet 2008;371:387-394.
7. Characterization of VTE events
In the Worcester County, Mass VTE Study
•60-70% of VTE events were considered to be
provoked by:
• Recent hospitalization (within 3 months)
• Surgery
• Trauma/fracture
• Pregnancy
1. Spencer FA, et al. Arch Intern Med 2007;167:1471-5.
2. Spencer FA, et al. J Thromb Thrombolysis 2009;28:401-9.
Risk for VTE increases with the
number of risk factors and
persists after hospital
discharge.
9. Adapted from: Greer IA. Bailliere’s Clin Obstet Gynaecol 1997;11:403-30.
The risk of DVT and PE is
increased by several factors,
including:
Factors intrinsic to the
patient
Factors related to
underlying disease or
medical condition
Factors introduced by
medical or surgical
treatment
• Age
• Obesity
• Immobility
• History of thrombosis
• Thrombophilia
• Varicose veins
• Venous insufficiency
• Pregnancy
• Trauma
• Heart failure/MI
• Malignancy
• Concomitant
medication
• Chemotherapy
• Orthopaedic surgery
• Major surgery
• Caesarean section
10. 1. VTE is common in hospital patients
2. VTE is fatal (acutely and long-term)
3. VTE is preventable (safely and
inexpensively)
4. Preventing VTE is the standard of
care for almost all hospital patients
in 2011
Slide courtesy of Dr. William Geerts.
Rationale for Thromboprophylaxis
13. Key steps to ensure compliance with ROP:
1.Development of written policy/guideline
2.Identifies clients at risk & provides VTE prophylaxis
3.Establishes measures of success, uses information to make improvements
4.Provides information to health professionals (on risks & prevention measures)
14. 1. Hospital commitment; committee, leadership
2. Follow the ACCP guidelines
3. Written hospital policy on prophylaxis
4. Keep it simple and standardize it
5. Use order sets, computer order entry
6. Make prophylaxis decision mandatory
7. Involve everyone – MD, RN, pharm, patients
8. Audit and feedback to improve best practices
8 steps:
Slide courtesy of Dr. William Geerts.
Local Strategies to Improve
Thromboprophylaxis Success
16. Audrey’s Story
Following a one week wait for surgery and the successful
removal of a benign tumour – Audrey developed a PE.
We are scared and worried about our surgery
or primary reason for being in the hospital as it
is. We rely on you to make us aware of any
possible complications. For me, the blood clot
was far scarier and worse than my brain
tumour and operation.
This experience with the blood clot has
impacted my life. It was the scariest and worst
experience I have ever had and it has left me
fearful and anxious.
“My plea to healthcare professionals: make sure you get people’s
attention, and make sure they fully understand their risks and
what can be done to prevent a blood clot.”
17. • Written hospital policy on VTE prophylaxis
• Opt-out policy for all medical and surgical in-
hospital patients
• VTE prophylaxis embedded in hospital order
sets
Policy ensures prophylaxis is considered
resulting in lower rates of VTE in
hospital setting
Hospital Commitment for VTE
Prophylaxis should include:
18. • Simplicity = single choice
• LMWH advantages over UFH:
• once a day administration
• lower rates of heparin induced
thrombocytopenia
• availability in prefilled syringes
Written hospital policy on
prophylaxis - Simplicity
LMWH: low molecular weight heparin; UFH: unfractionated heparin
19. • Due to differences in LMWH molecule size
and charge, longer chained and more
charged LMWHs like tinzaparin do not
appear to require dose adjustments in
patients with:
• impaired renal function1
• renal failure2,3
• on haemodialysis2,3
• Dose reduction may be necessary with
shorter chain LMWHs (i.e. enoxaparin)
Use of LMWHs in
Renal Impairment
1. Mahé O, et al.Thromb Haemost 2007;97:581-6.
2. PROTECT Investigators. N Engl J Med 2011;364:1305-14.
3. Nutescu EA, et al. Ann Pharmacother 2009;43:1064-83.
20. 1. Hospital commitment, committee, continued
leadership
2. Written hospital policy on prophylaxis
3. Keep policy simple and standardize it
4. Use embedded order sets &/or computer
order entry
5. Make prophylaxis decision mandatory
(i.e. opt-out policy)
1. Involve everyone – MD, RN, pharm, patients
2. Audit and feedback essential to measure
success and identify problems areas
Implementation
Slide courtesy of Dr. William Geerts.
21. 96%
Success with Policy and Embedding
Appropriate Prophylaxis*
(use in General IM Patients)
9%
2003 2007 2008 2009
21%
100%
75%
50%
25%
0
60%
*based on direct chart audit
Quality improvement in action!Slide courtesy of Dr. William Geerts.
22. Vigilance is Key:
Appropriate Prophylaxis* Use in
General IM Patients
9%
2003 2007 2008 2009 2010
21%
100%
75%
50%
25%
0
60%
96%
*based on direct chart audit
We opened the champagne too soon!
72%
Slide courtesy of Dr. William Geerts.
24. •Best practices in VTE
prophylaxis
•Clinical order set
•Audit material
•Health Professional
education material
•Patient education
material
The Content
25. • Reginald E. Smith, PharmD, ACPR, (Chair) Clinical
Pharmacy Specialist, Thrombosis Clinic, BC
• William Geerts, MD, FRCPC, National lead, VTE Prevention,
Safer Healthcare Now! Thromboembolism Specialist;
Professor of Medicine, University of Toronto, ON
• Artemis Diamantouros, BScPharm, MEd, National
Coordinator, VTE Prevention, Safer Healthcare Now!; KT
Pharmacist, ON
• Glenn Whiteway, BScPharm, PharmD, Pharmacy Clinical
Manager; Adjunct Professor, Dalhousie University, NB
• Mary Pederson, BScPharm, Clinical Practise Leader, AB
• Patrick Robertson, BSP, PharmD, Manager Pharmacy
Services, SK
• William Semchuk, MSc, PharmD, FCSHP, Manager
Pharmacy Services, SK
• Ritesh Mistry, MD, CCFP, Hospitalist; Clinical Assistant
Professor, McMaster University, ON
Developed by Canadian experts
26. • Sylvie Desmarais, MD, FRCPC, CSPQ, Internal and
Vascular Medicine Internist, QC
• James Douketis, MD, FRCPC, FACP, FCCP,
Professor, McMaster University, ON
• Jeannine Kassis, MD, FRCPC, Hematologist;
Professor of Medicine, Université de Montréal, QC
• Robin McLeod, MD, FRCSC, FACP, Professor of
Surgery and Health Policy, University of Toronto, ON
• Otto Moodley, MD, FRCPC, Clinical Hematologist,
SK
Reviewed by Canadian experts
28. Weight Based vs. Fixed Dosing
• fixed doses of LMWH in a prefilled syringe (i.e.
tinzaparin 4 500 U subcutaneously once daily) is
the simplest regimen for most patients.
• obese patients (>100 kg, BMI>35 kg/m2
) require
higher doses of LMWH than the non-obese
• use fixed dosing for patients between 50-100 kg
and adjust dosing for others
Prevention of VTE in Hospitalized
Patients:
Summary of Good Practice
29. Weight Dalteparin
Dose
Enoxaparin
Dose
Tinzaparin
Dose
<40 kg 2 500 U SC
once daily
30 mg SC
once daily
3 500 U SC
once daily
40-100 kg 5 000 U SC
once daily
40 mg SC
once daily
4 500 U SC
once daily
101-150 kg 5 000 U SC BID 40 mg SC BID 10 000 U SC
once daily
151-200 kg 40 U/kg SC
BID
0.4 mg/kg SC
BID
14 000 U SC
once daily
Prevention of VTE in Hospitalized
Patients:
Summary of Good Practice
eGFR >30 mL/min
In patients with impaired renal function (<30 mL/min):
Dalteparin: no dose adjustment is required.
Enoxaparin: a dosage adjustment is recommended since enoxaparin appears to accumulate in this patient
group and may increase risk of bleeding.
Tinzaparin: no dose adjustment of tinzaparin at prophylaxis doses is needed in patients with impaired renal
function1
, renal failure2,3
, or on hemodialysis2,3
.
Speaker Notes:
Venous Thromboembolism is the collective term for deep vein thrombosis and pulmonary embolism.
It may help to refer to DVTs as vein blood clots to patients to help them differentiate between blood clots in the legs and blood clots in the brain (stroke).
50% of DVTs produce no symptoms or signs, with the first awareness of a DVT being a pulmonary embolism (PE).
Speaker Notes:
One serious risk of venous thrombosis is part of the clot breaking away and being carried by the blood to the lungs.
This is known as a pulmonary embolism (PE).
The clot interferes with oxygenation of blood in the lungs and can therefore be fatal.
Speaker Notes:
Approximately 50% of patients have some of the expected symptoms and signs of DVT.
However, most hospitalized patients, will have no symptoms or signs.
Clinical diagnosis is unreliable, thus definitive diagnosis requires a Doppler ultrasound.
Speaker Notes:
This table from the ACCP Consensus Guidelines highlights the risk for venous thromboembolic disease in patients that have not been prophylaxed.
Medical patients have a prevalence of DVT in the absence of prophylaxis, of up 10% to 20%, while critical care patients have a 10% to 80% risk. It is important to note that these percentages represent asymptomatic DVTs.
Surgery patients have had most of the attention with regard to VTE prophylaxis.
Unlike surgery patients, the majority of prophylaxis-eligible medical patients are not receiving any prophylaxis or appropriate prophylaxis.
Reference:
Geerts WT, et al. Chest. 2008;358:381S-453S.
Speaker Notes:
In the UK, PE following DVT causes between 25,000 and 32,000 deaths each year, this exceeds the combined total deaths from breast cancer, AIDS and traffic accidents.
References:
UK House of Commons Health Committee. HC 99. Published on 8 March 2005.
Cohen AT, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008;371:387-394.
Speaker Notes:
The 2009 study examined all patients (n=1 567 patients) with a first-time VTE in Worchester County, Massachusetts from 1999 to 2003.
The study also found that:
72% of patients were “community acquired” VTE
20% of all events were unprovoked
30% were thought to be related to malignancy
Using an expected rate of 60% - that means that in Ontario the hospital-acquired VTE rate is about 8 000/year.
References:
Spencer FA, et al. Venous thromboembolism in the outpatient setting. Arch Intern Med. 2007;167:1471-5.
Spencer FA, et al. Incidence rates, clinical profile, and outcomes of patients with venous thromboembolism. The Worcester VTE study. J Thromb Thrombolysis. 2009;28:401-409.
Heit J, et al. Relative impact of risk factors for deep vein thrombosis and pulmonary embolism: a population-based study. Arch Intern Med. 2002;162:1245–1248.
Heit J. The Epidemiology of Venous Thromboembolism in the Community. Arterioscler Thromb Vasc Biol. 2008;28: 370–372.
Speaker Notes:
“Patients without risk factors for VTE are called outpatients.” G. Maynard (2010)
Epidemiological data suggest an incidence in the general population of:1
160 per 100,000 for DVT
120 per 100,000 for PE
In those over age 65 this increases to:2
655 per 100,000 for DVT (4-fold increase)
255 per 100,000 for PE
References:
O’Shaughnessy D.F. Haemostasis and Thrombosis: Current Clinical Practice: Low-Molecular-Weight Heparins in The Prophylaxis and Treatment of Thrombo-Embolic Disease. Hematol. 2000;4:373-380.
Stein PD, et al. Venous thromboembolism according to age: the impact of an aging population. Arch Intern Med. 2004;164:2260-2265.
Speaker Notes:
60-70% of all VTE is hospital-acquired (i.e. this is a public health issue).
Pulmonary embolism is the commonest preventable cause of hospital death.
Speaker Notes:
Required Organizational Practice (ROP) for VTE.
Speaker Notes:
The ROP provides key compliance tests, and more importantly key steps to ensure hospital-wide compliance.
Speaker Notes:
Remind the groups that patients at risk of VTE can look quite different.
Speaker Notes:
This is a real story.
Here is more of it:
I was in a hospital bed attached to an IV pole for one week waiting for my surgery. My surgery was successful, although the anesthesia left me feeling unwell. I went home to recuperate but continued to feel unwell, and had limited mobility due to an ongoing problem with my leg. Five days after I was released from hospital I could not stop coughing and I felt quite faint. Upon return to the ER it was discovered I had an enormous blood clot in my lungs- both of them. I ended up in the ICU on an anticoagulant and had to have special medication to dissolve the clot because it was so big and threatened my life. This experience with the blood clot has impacted my life. It was the scariest and worst experience I have ever had and it has left me fearful and anxious. It was a horrifying experience and one I never want to go through again, and I hope no one else has to go through either.
Speaker Notes:
Because of differences in the molecules, long chained/charged innohep and UFH can better bind to endothelial cells, be cleared by the reticulo-endothelial pathway, and are less affected/do not appear to accumulate in patients with renal impairment
Tinzaparin can be safely used in patients with CrCl below 30 mL/min.
References:
Mahé O, et al. Tinzaparin and enoxaparin given at prophylactic dose for eight days in medical elderly patients with impaired renal function: a comparative pharmacokinetic study. Thromb Haemost. 2007;97:581-6.
PROTECT Investigators. Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med. 2011;364:1305-14.
Nutescu EA, et al. Low-molecular-weight heparins in renal impairment and obesity: available evidence and clinical practice recommendations across medical and surgical settings. Ann Pharmacother. 2009;43:1064-83.
Speaker Notes:
This data shows the VTE prophylaxis audit outcomes for one hospital between 2003 and 2009. It clearly demonstrates the success and improvement in VTE prophylaxis when a hospital has VTE protocols, embedded order sets, simple LMWH dosing, regular audits and staff awareness.
Speaker Notes:
This data is from the same hospital, with the addition of the audit data from 2010. It shows that despite well developed policies and systems, vigilance and continued staff awareness is key to continued success.
Speaker Notes:
The VTE Prevention Simplified Kit was developed by a group of Canadian experts to address a need in hospitals setting up protocols to meet the Accreditation Canada ROP.
These experts developed tools, rather than policies or guidelines, to assist hospitals with the implementation of the VTE prophylaxis ROP.
All of the material has been provided as electronic templates in order that hospitals may adapt the material to meet their own policies and procedures.
The focus of this kit is on best practices in the use of tinzaparin or innohep®.
Speaker Notes:
The kit has 4 main sections:
Introduction: introduction to kit and Best practices in VTE prophylaxis
Tools: Clinical order set, audit material
Education: healthcare professional and patient education material
Other: room to add additional Clinical order sets and information in the future
Speaker Notes:
These Canadian experts developed and approved all of the material.
Speaker Notes:
These Canadian specialists reviewed and approved all of the material.
Speaker Notes:
Prophylaxis of VTE works best when there is a system-wide approach within a hospital. The best way to accomplish this is to embed orders for prophylaxis in clinical order sets, such that prophylaxis is routine and inclusive.
Limiting choices for VTE prophylaxis to keep it simple. Only one or two choices are sufficient in most situations.
The summary of good practice reviews all of the above and provides expert opinion.
UFH:low dose unfractionated heparin
LMWH: low molecular weight heparin
Speaker Notes:
There is evidence that obese patients (&gt;100 kg, BMI&gt;35 kg/ m 2 ) require higher doses of LMWH than non-obese patients. However, fixed doses of LMWH in a prefilled syringe (i.e. tinzaparin 4 500 U subcutaneously once daily) is the simplest regimen for most patients.
One way to solve this issue on the clinical order set is to have a fixed dose for the most common weight ranges, with adjusted dosing for those at the weight extremes (&lt;50 or &gt;100 kg).
Another consideration is that fixed dose syringes reduce costs with less wastage. They also reduce errors as patient weights and dosing do not need to be determined.
Speaker Notes:
The above dosing recommendations are those of the VTE Prevention Simplified experts.
Different policies/dosing for weight categories exist in hospitals across Canada. Again, the templates supplied can be modified/ adjusted to conform with hospital policy.
sc: subcutaneously
1. Mahé O, et al. Thromb Haemost. 2007;97:581-6; 2. PROTECT Investigators. N Engl J Med. 2011;364:1305-14; 3. Nutescu EA, et al. Ann Pharmacother. 2009;43:1064-83. FRAGMIN Product Monograph. Pfizer Canada Inc. January 6, 2014; LOVENOX Product Monograph. sanofi-aventis Canada Inc. December 20, 2013; INNOHEP Product Monograph. LEO Pharma Inc. February 3, 2011.
Speakers Notes:
Example of an opt-out clinical order set with prophylaxis embedded.
This “box” is supplied electronically and can be embedded into any hospital order set.
Speakers Notes:
Importantly, the expert committee believes that all medical and surgical patients should receive thromboprophylaxis as they are all at risk.
However, there are precautions and contraindications that may alter time of dosing or type of thromboprophylaxis.
Speakers Notes:
These contraindications are specific to innohep®. This is not a complete list.
Reference:
innohep® Product Monograph. Leo Pharma Inc, February 2011.
Speaker Notes:
Implementation of a VTE prophylaxis policy includes raising awareness of VTE risks amongst healthcare workers and patients.
It is important that dissemination of the information be done by multiple methods to reach the greatest number of healthcare professionals.
To assist with implementation this slide deck as well as a shorter version have been developed to increase staff awareness.
Posters for healthcare professionals and patients have also been developed to raise awareness and keep VTE prophylaxis top of mind.
Examples of how to spread the word:
Grand Rounds
In-service sessions
Posters for medical staff rooms
Patient awareness and education
Please note that the audit material is reviewed in a separate slide deck.