Clinical trial NCT02597218: Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy. A Cohort Study.
Official title: Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy in a High-volume Center. A Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Embolism
Venous Thrombosis
Portal Thrombosis
Keywords: Hepatectomy
Prophylaxis
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years following hepatectomy of any kind for oncologic/non-oncologic disease between 04/09/2012 and 08/28/2015 were enrolled. Follow-up concluded 90 days after surgery or at occurence of event (Venous thromboembolism / portal thrombosis / death).

Brief summary: Observational. Retrospective cohort.

Detailed description: Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). It is a common, potentially lethal disorder that can occur among postoperative patients. Liver surgery implies a prothrombotic state, as a result of an alteration of the equilibrium between synthesis and use of pro and anti coagulant factors after a parenquimal resection. The use of antithrombotic prophylaxis following surgery is not standarized, and current practices vary depending on the attendant surgeon's particular experience or hospital's customs and habits.

In published research, postoperative patients have been studied as a whole so far. There is little evidence regarding patients undergoing hepatectomy. Furthermore, the use and need of extended prophylaxis remains unexplored in this group of patients.

The objetives of the following study are:

* To estimate the incidence of symptomatic venous thromboembolism (VTE) \[deep vein thrombosis (DVT), pulmonary embolism (PE) and fatal PE\] in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
* To estimate the incidence of portal thrombosis (PT) in a third level center in patients undergoing any hepatectomy within 90 days after surgery.
* To identify and describe factors associated to the development of VTE in patients following hepatectomy.
* To identify and describe factors associated to the development of PT in patients following hepatectomy.
* To describe major bleedings or minor but clinically relevant bleedings during the period in which those patients received chemical thromboprophylaxis.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years old.
* Following hepatic surgery.

Exclusion Criteria:

* Living donor
* Venous thromboembolism within 6 months previous to surgery.

Primary outcomes:
measure: Venous thromboembolism (VTE)
timeFrame: 90 days following surgery
Secondary outcomes:
measure: Portal Thrombosis (PT)
timeFrame: 90 days following surgery
measure: Minor bleeding
timeFrame: 90 days following surgery
measure: Major bleeding
timeFrame: 90 days following surgery
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Martín de Santibañes, Dr
role: STUDY_DIRECTOR
References:
citation: Rasmussen MS. Preventing thromboembolic complications in cancer patients after surgery: a role for prolonged thromboprophylaxis. Cancer Treat Rev. 2002 Jun;28(3):141-4. doi: 10.1016/s0305-7372(02)00043-9.
citation: Ejaz A, Spolverato G, Kim Y, Lucas DL, Lau B, Weiss M, Johnston FM, Kheng M, Hirose K, Wolfgang CL, Haut E, Pawlik TM. Defining incidence and risk factors of venous thromboemolism after hepatectomy. J Gastrointest Surg. 2014 Jun;18(6):1116-24. doi: 10.1007/s11605-013-2432-x. Epub 2013 Dec 13.
citation: Caprini JA, Arcelus JI, Hasty JH, Tamhane AC, Fabrega F. Clinical assessment of venous thromboembolic risk in surgical patients. Semin Thromb Hemost. 1991;17 Suppl 3:304-12.
citation: Collins R, Scrimgeour A, Yusuf S, Peto R. Reduction in fatal pulmonary embolism and venous thrombosis by perioperative administration of subcutaneous heparin. Overview of results of randomized trials in general, orthopedic, and urologic surgery. N Engl J Med. 1988 May 5;318(18):1162-73. doi: 10.1056/NEJM198805053181805. No abstract available.
citation: Prevention of fatal postoperative pulmonary embolism by low doses of heparin. An international multicentre trial. Lancet. 1975 Jul 12;2(7924):45-51.
citation: Kiil J, Kiil J, Axelsen F, Andersen D. Prophylaxis against postoperative pulmonary embolism and deep-vein thrombosis by low-dose heparin. Lancet. 1978 May 27;1(8074):1115-6. doi: 10.1016/s0140-6736(78)90297-0.
citation: Pezzuoli G, Neri Serneri GG, Settembrini P, Coggi G, Olivari N, Buzzetti G, Chierichetti S, Scotti A, Scatigna M, Carnovali M. Prophylaxis of fatal pulmonary embolism in general surgery using low-molecular weight heparin Cy 216: a multicentre, double-blind, randomized, controlled, clinical trial versus placebo (STEP). STEP-Study Group. Int Surg. 1989 Oct-Dec;74(4):205-10.
citation: Mismetti P, Laporte S, Darmon JY, Buchmuller A, Decousus H. Meta-analysis of low molecular weight heparin in the prevention of venous thromboembolism in general surgery. Br J Surg. 2001 Jul;88(7):913-30. doi: 10.1046/j.0007-1323.2001.01800.x.
citation: Gould MK, Garcia DA, Wren SM, Karanicolas PJ, Arcelus JI, Heit JA, Samama CM. 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 Feb;141(2 Suppl):e227S-e277S. doi: 10.1378/chest.11-2297.
citation: Lyman GH, Khorana AA, Kuderer NM, Lee AY, Arcelus JI, Balaban EP, Clarke JM, Flowers CR, Francis CW, Gates LE, Kakkar AK, Key NS, Levine MN, Liebman HA, Tempero MA, Wong SL, Prestrud AA, Falanga A; American Society of Clinical Oncology Clinical Practice. Venous thromboembolism prophylaxis and treatment in patients with cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013 Jun 10;31(17):2189-204. doi: 10.1200/JCO.2013.49.1118. Epub 2013 May 13.
citation: Barton JS, Riha GM, Differding JA, Underwood SJ, Curren JL, Sheppard BC, Pommier RF, Orloff SL, Schreiber MA, Billingsley KG. Coagulopathy after a liver resection: is it over diagnosed and over treated? HPB (Oxford). 2013 Nov;15(11):865-71. doi: 10.1111/hpb.12051. Epub 2013 Jan 29.
citation: Bezeaud A, Denninger MH, Dondero F, Saada V, Venisse L, Huisse MG, Belghiti J, Guillin MC. Hypercoagulability after partial liver resection. Thromb Haemost. 2007 Dec;98(6):1252-6.
citation: Tzeng CW, Katz MH, Fleming JB, Pisters PW, Lee JE, Abdalla EK, Curley SA, Vauthey JN, Aloia TA. Risk of venous thromboembolism outweighs post-hepatectomy bleeding complications: analysis of 5651 National Surgical Quality Improvement Program patients. HPB (Oxford). 2012 Aug;14(8):506-13. doi: 10.1111/j.1477-2574.2012.00479.x. Epub 2012 May 15.
citation: Smyrniotis V, Farantos C, Kostopanagiotou G, Arkadopoulos N. Vascular control during hepatectomy: review of methods and results. World J Surg. 2005 Nov;29(11):1384-96. doi: 10.1007/s00268-005-0025-x.
citation: Yoshiya S, Shirabe K, Nakagawara H, Soejima Y, Yoshizumi T, Ikegami T, Yamashita Y, Harimoto N, Nishie A, Yamanaka T, Maehara Y. Portal vein thrombosis after hepatectomy. World J Surg. 2014 Jun;38(6):1491-7. doi: 10.1007/s00268-013-2440-8.
citation: Weiss MJ, Kim Y, Ejaz A, Spolverato G, Haut ER, Hirose K, Wolfgang CL, Choti MA, Pawlik TM. Venous thromboembolic prophylaxis after a hepatic resection: patterns of care among liver surgeons. HPB (Oxford). 2014 Oct;16(10):892-8. doi: 10.1111/hpb.12278. Epub 2014 May 28.
citation: Tzeng CW, Curley SA, Vauthey JN, Aloia TA. Distinct predictors of pre- versus post-discharge venous thromboembolism after hepatectomy: analysis of 7621 NSQIP patients. HPB (Oxford). 2013 Oct;15(10):773-80. doi: 10.1111/hpb.12130. Epub 2013 Jul 22.
citation: Agnelli G, Bolis G, Capussotti L, Scarpa RM, Tonelli F, Bonizzoni E, Moia M, Parazzini F, Rossi R, Sonaglia F, Valarani B, Bianchini C, Gussoni G. A clinical outcome-based prospective study on venous thromboembolism after cancer surgery: the @RISTOS project. Ann Surg. 2006 Jan;243(1):89-95. doi: 10.1097/01.sla.0000193959.44677.48.
citation: Bergqvist D, Agnelli G, Cohen AT, Eldor A, Nilsson PE, Le Moigne-Amrani A, Dietrich-Neto F; ENOXACAN II Investigators. Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer. N Engl J Med. 2002 Mar 28;346(13):975-80. doi: 10.1056/NEJMoa012385.
citation: Posadas-Martinez ML, Vazquez FJ, Giunta DH, Waisman GD, de Quiros FG, Gandara E. Performance of the Wells score in patients with suspected pulmonary embolism during hospitalization: a delayed-type cross sectional study in a community hospital. Thromb Res. 2014 Feb;133(2):177-81. doi: 10.1016/j.thromres.2013.11.018. Epub 2013 Nov 25.