VTE in the Trauma Population

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VTE in the Trauma Population Erik Peltz, D.O. February 11 th, 2015 * contributions from Eduardo Gonzalez, M.D. University of Colorado T-32 Research Fellow

The problem. VTE - Scope of the Problem One of the most common causes of preventable death in hospitalized patients 150,000 200,000 deaths per year. 1/3 Postoperative Pulmonary embolism mortality in the US, 1979 1998 Arch Intern Med 2003 Risk of fatal perioperative PE approximately 0.8% International Multicentre Trial. Lancet 1975 Collins et al. N Engl J Med. 1988 Implications for the patient Implications for healthcare

VTE Agency for Healthcare Research and Quality 300,000 600,000 annual DVT; 100,000 200,000 Deaths from PE DVT after surgery 20%, PE 1-2%, Fatal 0.1-0.4% CMS 2015 Postoperative Hip Fracture PSI VTE prevention is a number one priority to improve safety in hospitals AHRQ

Identifying At Risk Patients Surgical patients may have a propensity for bleeding.. or clotting and/or both Prophylaxis may trade one complication for another Risk benefit analysis

Identifying At Risk Patients Surgical patients may have a propensity for bleeding.. or clotting or both Prophylaxis may trade one complication for another Risk benefit analysis

Contributed by E. Gonzalez, MD. T32 research fellow

Identifying At Risk Surgical patients may have a propensity for bleeding.. or clotting or both Therapy or prophylaxis may trade one complication for another Risk benefit analysis

Identifying At Risk Spectrum of Coagulation with Illness or Injury Journal TACS 2014

Identifying At Risk Surgical patients may have a propensity for bleeding.. or clotting or both Therapy or prophylaxis may trade one complication for another Risk benefit analysis

Risk Assessment Models Caprini Risk Assessment Model Bahl et al. Ann Surg 2010

Risk Assessment Models Caprini Risk Assessment Model Bahl et al. Ann Surg 2010 Caprini, Dis Mon. 2005

Risk Assessment Models Thrombosis Risk Assessment as a Guide to Quality Patient Care Caprini, Dis Mon. 2005

Risk Assessment Models Prevention of Venous Thromboembolism Geerts, CHEST. 2001

Risk Assessment Models Caprini Risk assessment model Bahl et al. Ann Surg 2010

The problem. Scope of the Problem 150,000 200,000 deaths per year. 1/3 Postoperative Risk of fatal perioperative PE approximately 0.8% Risk Assessment Tools DVT rate 0-20% or 10-80% Trauma is a high risk DVT rate without prophylaxis Acute spinal cord injury 90% Trauma 58% Elective hip surgery 50% major general surgery 25% Neurosurgical patients 22% Gonzalez, Moore. submitted for publication 2015

The problem. Scope of the Problem Untreated proximal DVT High incidence DVT in untreated trauma (surgical) patients 17% incidence symptomatic PE 50% incidence asymptomatic PE on screening studies Major Bleeding: fatal, symptomatic in critical organ, new / worsening intra-cranial hemorrhage, retroperitoneal bleeding that causes hemodynamic instability, decreases Hgb > 2mg/dl, requires > 2u PRBC or interventional / surgical procedure International Surgical Thrombosis Forum - 2006 Gonzalez, Moore. submitted for publication 2015

Trauma 2C

Trauma - PCD Pneumatic Compression Devices SCD s, IPC s, including foot pumps Increase peak venous velocity Keith et al. Arch Surg. 1992 In vivo fibrinolytic activity Jacobs et al. J. Trauma. 1996 0 60% reduction in VTE Increase risk skin breakdown 4 fold (5-6%) May have injury specific benefit in Neurotruama

IPC CHEST: Trauma PCD, Elastic Stockings IPC vs no Tx: Studies were limited by small samples, lack of blinding, unclear concealment of allocations sequence, use of fibrinogen leg scanning to Adherence to Tx identify asymptomatic DVT Gould et al. Chest 2012

Trauma - PCD PCD - EAST: Level III recommendation Knudson et al. J Trauma 1992 12% PCD vs 8% LDUH No better that no prophylaxis Knudson et a. J Trauma 1996 prospective eval of 372 trauma patients AV foot pump 5.7% Rogers et al. J Trauma 2002 PCD s 2.5% LMWH 0.8% Knudson et al. J Trauma 1994 PCD benefit in Neurotrauma only

Trauma - PCD PCD - EAST: Level III recommendation Agency of Healthcare Research and Quality Velmahos et al. J. Trauma 2000 Meta-analysis: pooled randomized trials No benefit to PCD over no prophylaxis Velmahos et al. JACS 1996 Prospective, 200 Trauma Patients, weekly doppler US PCD vs LDUH vs PCD + LDUH - No Difference. VTE 13%

Trauma - Heparin 2C

Trauma - Heparin Unfractionated Heparin Little distinction is made with evidence for LDUH vs LMWH

Trauma Cannot support LDUH alone II LMWH

Trauma III LMWH

Trauma - Heparin LDUH- EAST: Knudson et al. J Trauma 1992 12% PCD vs 8% LDUH No better than no prophylaxis Cannot support LDUH alone Velmahos et al. JACS 1996 Prospective, 200 Trauma Patients, weekly doppler US PCD vs LDUH vs PCD + LDUH - No difference. VTE 13%

Trauma - Heparin Low Molecular Weight Heparin (LMWH) All DVT Proximal Knudson et a. J Trauma 1996 prospective eval of 372 trauma patients AV foot pump 5.7% PCD s 2.5% LMWH 0.8% Geerts et al. NEJM 1996 randomized 265 LDH vs LMWH DVT rate LDH 44% vs LMWH 31% (p=0.014) LDH 15% vs LMWH 6% (p=0.012) Major Bleeding Serial Duplex US Venography LDH 0.6% vs LMWH 2.9% (p=0.12)

Trauma - Heparin Geerts et al. N Engl J Med 1996; 335:701-7.

Trauma IVC Filter 2C

Trauma III IVC filter

IVC filter Success rate preventing PE from legs 98% Greenfield et al, J Vasc Surg 2000 1.5% PE 1 yr patency 82 96% 2 yr patency 96% Rogers, Shackford et al. JACS 1995 Wilson et al Neurosurgery 1994 Greenfield caval occlusion 3.5% J Vasc Surg 2000 < 22% are ever retrieved!! Karmy-Jones. J Trauma 2007

IVC filter A fair amount of class II and III data that support VCF use has accumulated in high-risk trauma patients without a (pre-filter placement) documented occurrence of DVT or PE. At this time, we recommend consideration of IVC filter insertion in patients without a documented DVT or PE who meet high-risk criteria and cannot be anticoagulated high risk patients 92% of PE s occur in 4 injury patterns 1) spinal cord injury with paraplegia / paralysis 2) severe closed head injury with a GCS 8 for > 48hrs 3) age > 55yrs with isolated long bone fractures 4) complex pelvic fractures associated with long bone fractures - Roger, Shackford et al. J Trauma 1993. - Winchell, Hoyt et al. J Trauma. 1994. 9,721 patients

Retrospective - 446 patients, 21 centers 51% lost to follow-up 22% retrieval rate 10% failed retrieval technical limitations Thrombus 6% Gunter-Tulip 4% Recovery 46% Optease 1.3% Migration 0.6% PE with filter in place 0.4% symptomatic

Prophylaxis in TBI 2C 2002

Prophylaxis in TBI J Trauma Acute Care Surg - 2012 Prospective, randomized, blinded, 2 Level I Trauma Centers Patients with TBI and bleed within 6 hours injury Low risk TBI Parkland Protocol CT stability at 24 hours Lovenox 30mg bid Placebo CT at 48 hours

Parkland Protocol Prophylaxis in TBI 25 % 29 % 43 % 53 % 64 % 58 % J TACS 2012 J Neurotrauma 2014

5.9% vs 3.6% (95% CI from -14 to 16%) 5.9% 3.6% J TACS

Predict Risk Benefit / Treat Trauma Patients are HIGH risk for DVT / PE PCD s may decrease VTE risk. Studies however have shown no benefit over no therapy. Non-compliance is high (25-60%). Potential benefit is then lost LDUH is not effective in trauma patients as single therapy LMWH is superior to LDUH in preventing proximal DVT. Risk reduction 58% IVC filters should be considered in high risk categories with contra-indications to anticoagulation LMWH safe in TBI with stable head CT 72hrs, 48hrs, 24hrs!?

Predict Risk Benefit / Treat General abdominal / pelvic surgery patients Cardiac surgery patients Thoracic surgery patients Craniotomy Spinal surgery Surgical oncology Bariatric surgery Pediatric Organ specific (pancrease, liver, etc) Orthopedic surgery Central venous catheters Hypercoagulable disorders

1. Saadeh, Y., et al., Chemical venous thromboembolic prophylaxis is safe and effective for patients with traumatic brain injury when started 24 hours after the absence of hemorrhage progression on head CT. The journal of trauma and acute care surgery, 2012. 73(2): p. 426-30. 2. Kim, J., et al., Preliminary report on the safety of heparin for deep venous thrombosis prophylaxis after severe head injury. The Journal of trauma, 2002. 53(1): p. 38-42; discussion 43. 3. Levy, A.S., et al., Pharmacologic thromboprophylaxis is a risk factor for hemorrhage progression in a subset of patients with traumatic brain injury. The Journal of trauma, 2010. 68(4): p. 886-94. 4. Phelan, H.A., et al., A randomized, double-blinded, placebo-controlled pilot trial of anticoagulation in low-risk traumatic brain injury: The Delayed Versus Early Enoxaparin Prophylaxis I (DEEP I) study. The journal of trauma and acute care surgery, 2012. 73(6): p. 1434-41. 5. Phelan, H.A., Pharmacologic venous thromboembolism prophylaxis after traumatic brain injury: a critical literature review. Journal of neurotrauma, 2012. 29(10): p. 1821-8. 6. Gould, M.K., et al., Prevention of VTE in nonorthopedic surgical patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest, 2012. 141(2 Suppl): p. e227s-77s. 7. Rogers, F.B., et al., Practice management guidelines for the prevention of venous thromboembolism in trauma patients: the EAST practice management guidelines work group. The Journal of trauma, 2002. 53(1): p. 142-64. 8. Moore, H.B., et al., Hyperfibrinolysis, physiologic fibrinolysis, and fibrinolysis shutdown: the spectrum of postinjury fibrinolysis and relevance to antifibrinolytic therapy. The journal of trauma and acute care surgery, 2014. 77(6): p. 811-7; discussion 817. 9. Bahl, V., et al., A validation study of a retrospective venous thromboembolism risk scoring method. Annals of surgery, 2010. 251(2): p. 344-50. 10. Caprini, J.A., Thrombosis risk assessment as a guide to quality patient care. Disease-a-month : DM, 2005. 51(2-3): p. 70-8. 11. Caprini, J.A., Risk assessment as a guide to thrombosis prophylaxis. Current opinion in pulmonary medicine, 2010. 16(5): p. 448-52. 12. Geerts, W.H., et al., Prevention of venous thromboembolism. Chest, 2001. 119(1 Suppl): p. 132S-175S. 13. Geerts, W.H., et al., A comparison of low-dose heparin with low-molecular-weight heparin as prophylaxis against venous thromboembolism after major trauma. The New England journal of medicine, 1996. 335(10): p. 701-7. 14. Pastorek, R.A., et al., The Parkland Protocol's modified Berne-Norwood criteria predict two tiers of risk for traumatic brain injury progression. Journal of neurotrauma, 2014. 31(20): p. 1737-43. 15. Gonzalez, E. and E.E. Moore, Venous Thromboembolism. Denver Health Medical Center Handbook of Surgical Critical Care, ed. F. Pieracci and E.E. Moore(2015): World Scientific Publishing, Imperial College Press.

Thanks to: Dr. Eduardo Gonzalez Dr. EE Moore Dr. A. Banerjee Dr. C. Silliman Dr. A. Sauaia Dr. H. Moore Dr. J. Harr Dr. T. Nydam A portion of this data supported by National Institute of General Medical Sciences grants: T32-GM008315 and P50-GM049222