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First
occurrence? Continue evaluation of other causes of symptoms
Consider prophylaxis if clinically indicated (See VTE Prophylaxis Algorithm)
No
1
In patients with a high clinical suspicion of DVT/PE, in the absence of contraindications it is recommended that treatment with anticoagulants be started while awaiting the outcome of diagnostic test(s).
2
Significant extremity swelling as evidenced by significant impact on performance status that affects quality of life, or is associated with phlegmasia or lymphedema
3
Anticoagulation after catheter removal can be stopped after 3 months.
4
Consider post-thrombotic syndrome if symptoms occur in same extremity as prior VTE
No
1
In patients with a high clinical suspicion of DVT/PE, in the absence of contraindications it is recommended that treatment with anticoagulants be started while awaiting the outcome of diagnostic test(s).
2
Significant extremity swelling: significant impact on performance status that affects quality of life, or is associated with phlegmasia or lymphedema
3
Consider post-thrombotic syndrome when symptoms occur in site of prior VTE
3
Submassive See Page 5
Pulmonary
Embolism (PE)1
Contra- Yes Consult Vascular Surgery
Massive
3 indications to
anticoagulation4 ? Follow-up
No Yes
Yes
Contra-
Treat with indications to
PE anticoagulant thrombolytics5? Yes
2 No
CT angiogram 3
confirmed ?
Systolic
Treat with systemic blood pressure
No
thrombolytics6 greater than
Yes 90 mmHg?
First No
occurrence of Continue evaluation of other causes of symptoms
PE? Consider prophylaxis if clinically indicated (See VTE Prophylaxis Algorithm)
No Consult
Vascular
No new defect Continue current management Surgery
2
CT angiogram
New defect See Box A on Page 5
1 4
In patients with a high clinical suspicion of DVT/PE, in the absence of contraindications it is recommended that treatment with anticoagulants be started while See Appendix A for Contraindications to Anticoagulation
awaiting the outcome of diagnostic test(s). For suspected PE, obtain the following: ECHO, Troponin level, BNP. 5
See Appendix B for Contraindications to Thrombolytics
2
If CT angiogram cannot be done, consider VQ scan 6
3 See Appendix F for Alteplase treatment and monitoring
Submassive pulmonary embolism (PE): Any PE that is not massive (see below).
Massive pulmonary embolism (PE):
Sustained hypotension (systolic blood pressure less than 90 mmHg for at least 15 minutes) or
Persistent bradycardia (Heart Rate less than 40 bpm with signs or symptoms of shock
Need for inotropic support
Department of Clinical Effectiveness V5
Copyright 2015 The University of Texas MD Anderson Cancer Center Approved by The Executive Committee of the Medical Staff 06/30/2015
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Andersons specific patient population; MD Andersons services and structure; and MD Andersons clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant or lactating women.
Treatment for all VTE Upper extremity DVT Withhold anticoagulation and monitor
2
Temporary
2 Yes Retrievable IVC Filter
Lower extremity DVT
contraindication to
or PE
anticoagulant?
No Permanent IVC Filter
Yes
Contra-
indications to
1
anticoagulation ?
Select anticoagulants Monitor patient per selected anticoagulation
No Patient Yes
See Appendix D for management instructions therapy (see respective appendices)*
on current *For patients with VTE and cancer,
anticoagulation continue anticoagulant therapy
therapy? Select anticoagulants indefinitely, or until cancer
No
See Appendix E for management instructions resolves, or if no contraindication emerges
Does
patient meet
outpatient criteria for Yes
anticoagulation
treatment? (See Admit patient for evaluation and treatment or if already
Appendix No
inpatient, continue with evaluation and treatment
C)
1
See Appendix A for Contraindications to Anticoagulation
2
Criteria to consider for placement of a retrievable filter
If temporary/limited time (less than or equal to 2-3 months) of contraindication to anticoagulants place a retrievable IVC filter.
Greater than 6 months survival expected
Performance Status less than or equal to 1
Department of Clinical Effectiveness V5
Copyright 2015 The University of Texas MD Anderson Cancer Center
Approved by The Executive Committee of the Medical Staff 06/30/2015
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Andersons specific patient population; MD Andersons services and structure; and MD Andersons clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant or lactating women.
APPENDIX D: Recurrent VTE Anticoagulation Therapy Options for patients currently on standard anticoagulant therapy
If peak factor Xa level is therapeutic and the VTE event is a symptomatic pulmonary embolism, place a permanent IVC filter.
Consider General Internal Medicine or Benign Hematology consult.
1
See recommendations for specific agents on Page 8.
2
Range may vary, based on specific institutional ranges.
TREATMENT MONITORING
Overlap warfarin (2.5 5 mg PO) with induction therapy (LMWH, Factor Xa Inhibitor, or UFH-SC) beginning on Day 1 of INR Goal: 2-3
therapy Baseline CBC with platelet count, aPTT/PT,
Continue LMWH/Factor Xa Inhibitor subcutaneously until INR greater than or equal to 2 for two days, AND patient has liver function tests
received at least 4-5 days of induction therapy overlap Follow-up for PT/INR within 3-5 days, then
at least every month if not more frequently
1
Use of warfarin in cancer patients has been shown to be less effective at preventing clot recurrence than LMWH.
Department of Clinical Effectiveness V5
Approved by The Executive Committee of the Medical Staff 06/30/2015
Copyright 2015 The University of Texas MD Anderson Cancer Center
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Andersons specific patient population; MD Andersons services and structure; and MD Andersons clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant or lactating women.
APPENDIX F: New Oral Anticoagulants (NOAC) (ATTENTION: Expert panels DO NOT RECOMMEND use of these drugs in patients with cancer.
A multidisciplinary consultation is strongly recommended with Benign Hematology, Cardiology, and/or General Internal Medicine). Each case needs to
be individually assessed prior to use of NOACs.
DABIGATRAN
DABIGATRAN DOSE MONITORING COMMENTS
After at least 5 days of induction therapy Routine monitoring of coagulation tests not required If creatinine clearance less than 30 mL/minute avoid use
(LMWH, Factor Xa Inhibitor, or UFH-SC), Baseline CBC with differential, renal function tests, Mild hepatic impairment no adjustment
begin dabigatran 150 mg PO twice daily after hepatic function tests, Anti-Factor Xa if clinically Moderate to severe hepatic impairment (Child Pugh class B or C)
last dose of Dalteparin, or indicated and available and patients with any hepatic disease associated with
12 hours after Enoxaparin, or coagulopathy avoid use
4 hours after UFH infusion is stopped Please be aware of drug interactions
Note:
Reasons to avoid use of New Oral Anticoagulants (NOAC) in the cancer population:
Limited number of patients with cancer studied in NOAC clinical trials No reversal agents available
Lack of standardized testing for monitoring Complicated drug-drug interactions with chemotherapy agents
APPENDIX F: New Oral Anticoagulants (ATTENTION: Expert panels DO NOT RECOMMEND use of these drugs in patients with cancer. A
multidisciplinary consultation is strongly recommended with Benign Hematology, Cardiology, and/or General Internal Medicine). Each case needs to
be individually assessed prior to use of NOACs.
Reasons to avoid use of New Oral Anticoagulants (NOAC) in the cancer population:
Limited number of patients with cancer studied in NOAC clinical trials No reversal agents available
Lack of standardized testing for monitoring Complicated drug-drug interactions with chemotherapy agents
60 mg PO Daily started after at least 5 days Routine monitoring of coagulation If creatinine clearance less than 15 mL/minute avoid use
of treatment with a parenteral anticoagulant tests not required If creatinine clearance between 15-50mL/minute dose reduce to 30mg PO Daily
If body weight less than or equal to 60 kg Baseline CBC with differential, Hepatic Impairment Mild no adjustment required
dose reduce to 30 mg PO daily renal function tests, hepatic Hepatic Impairment Moderate-Severe avoid use
function tests, Anti-Factor Xa if If patient is on a concomitant P-glycoprotein inhibitors (quinidine, verapamil,
clinically indicated and available azithromycin, clarithromycin, erythromycin, itraconazole, and ketoconazole)
dose reduce to 30mg PO daily
1
Apixaban and Edoxaban are currently not on the MD Anderson formulary.
APPENDIX G: Thrombolytics
ALTEPLASE
C1: Critical Care, Emergency Department, Operating Room Utilization of a portable cardiac monitor with a
Alteplase 100 mg IV over 2 hours
C2: Monitored Intermediate Care physician/designee at bedside
C3: Acute Care Unit Neurologic exam to rule out intracranial bleeding
Vital signs per routine, based on level of care
HOLD ANTICOAGULATION while receiving
alteplase treatment
SUGGESTED READINGS
EINSTEIN Investigators, Bauersachs R, Berkowitz SD, et al. (2010). Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med.; 363:24992510.
EINSTEINPE Investigators, Bller HR, Prins MH, et al. (2012). Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med.; 366:12871297.
Cohen AT, Spiro TE, Bller HR, et al; MAGELLAN Investigators. (2013). Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med.; 368: 513523.
Jaff, M., McMurty, S., Archer, S.L., et al. (2011). Management of massive and submassive pulmonary embolism, illiofemoral deep vein thrombosis, and chronic thromboembolic pulmonary
hypertension: A scientific statement from the American Heart Association. Circulation, 123, 1788-1830.
Khorana, A.A., Streiff, M.B., Farge, D., et al. (2009). Venous thromboembolism prophylaxis and treatment in cancer: a consensus statement of major guidelines panels and call to action. Journal
of Clinical Oncology, 2009 Oct 10, 27(29), 4919-26. Epub 2009 Aug 31.
Lee, AY. (2009). Anticoagulation in the treatment of established venous thromboembolism in patients with cancer. Journal of Clinical Oncology, 2009 Oct 10;27(29), 4895-901. Epub 2009 Sep
8. Review
Lee, AY, (2012). Treatment of established thrombotic events in patients with cancer. Thrombosis Research, 129 suppl, S146-S453.
Lee, AY, et al. (2003). CLOT Trial: fragmin study in cancer patients. New England Journal of Medicine, 349, 146-53.
Lee, AY. (2014) Prevention and treatment of venous thromboembolism in patients with cancer. Hematology. 2014(1) 312-317
Levine MN, Gu C, Liebman HA, et al. (2012). A randomized phase II trial of apixaban for the prevention of thromboembolism in patients with metastatic cancer. J Thromb Haemost.; 10:807814.
Lyman, G.H., Khorana, A.A., Falanga, A., et al. (2007). American Society of Clinical Oncology guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients
with cancer. Journal of Clinical Oncology, (34), 5490-505. Epub 2007 Oct 29. Review.
Lyman, G.H., Khorana, A.A., Falanga, A., et al. (2013). Venous thromboembolism prophylaxis and treatment in patients with cancer; American Society of Clinical Oncololgy Practice Guideline
Update. Journal of Clinical Oncology, (31), 2189-2204.
Merli, G., Spiro, T.E., Olsson, C., et al. (2001). Subcutaneous enoxaparin once or twice daily compared with intravenous unfractionated heparin for treatment of VTE. Annals of Internal Medicine,
134, 191-202.
The NCCN Clinical Practice Guidelines in Oncology Venous Thromboembolic Disease (Version V.2.2014). 2014 National Comprehensive Cancer Network, Inc. Retrieved from NCCN.org.
Accessed [January 06, 2014].
Schulman S, Kearon C, Kakkar AK, et al. (2009). RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med.; 361:23422352.
Schulman S, Kearon C, Kakkar AK, et al. (2013). RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
N Engl J Med.; 368:709718.
Streiff, M.B. (2009). Diagnosis and initial treatment of venous thromboembolism in patients with cancer. Journal of Clinical Oncology, 27(29), 4889-94. Epub 2009 Sep 8. Review.
Department of Clinical Effectiveness V5
Copyright 2015 The University of Texas MD Anderson Cancer Center Approved by The Executive Committee of the Medical Staff 06/30/2015
This practice algorithm has been specifically developed for MD Anderson using a multidisciplinary approach and taking into consideration circumstances particular to MD Anderson,
including the following: MD Andersons specific patient population; MD Andersons services and structure; and MD Andersons clinical information. Moreover, this algorithm is not
intended to replace the independent medical or professional judgment of physicians or other health care providers. This algorithm should not be used to treat pregnant or lactating women.
DEVELOPMENT CREDITS
This practice consensus algorithm is based on majority expert opinion of the VTE workgroup consisting of Faculty at the University of Texas MD Anderson
Cancer Center. It was developed using a multidisciplinary approach that included input from the faculty and staff. The core team included:
Jean-Bernard Durand, MD
Carmen Escalante, MD
Josiah Halm, MD
Steven Y. Huang, MD
Tam Thi Thanh Huynh, MD
Michael Kroll, MD
Tara Lech, PharmD, RPh
Deborah McCue, PharmD
Joseph L. Nates, MD
Cristhiam Rojas Hernandez, MD
Katy M. Toale, PharmD
S. Wamique Yusuf, MD
Ali Zalpour, PhramD