Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy. A Cohort Study.

Pulmonary Embolism Clinical Trial

Official title:

Incidence of Venous Thromboembolic Disease and Portal Vein Thrombosis After Hepatectomy in a High-volume Center. A Cohort Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02597218
• Other study ID #: 2611
• Status: Recruiting
• Start date: October 2015
• Est. completion date: February 2020

Study information

• Verified date: August 2019
• Source: Hospital Italiano de Buenos Aires
• Contact: Juan Ignacio Trobbiani, Dr
• Phone: +542914253231
• Email: juan.trobbiani[@]hospitalitaliano.org.ar
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational. Retrospective cohort.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: February 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Older than 18 years old.

• Following hepatic surgery.

Exclusion Criteria:

• Living donor

• Venous thromboembolism within 6 months previous to surgery.

Related Conditions & MeSH terms

• Embolism
• Portal Thrombosis
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Capital Federal	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (20)

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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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Erratum in: J Gastrointest Surg. 2014 Apr;18(4):887. Kheng, Marian [corrected to Kheng, Marin]. — View 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. Erratum in: Chest. 2012 May;141(5):1369. — View Citation

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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. Review. — View Citation

Mismetti P, Laporte S, Darmon JY, Buchmüller 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. — View 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. — View Citation

Posadas-Martínez ML, Vázquez FJ, Giunta DH, Waisman GD, de Quirós FG, Gándara 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. — View Citation

Prevention of fatal postoperative pulmonary embolism by low doses of heparin. An international multicentre trial. Lancet. 1975 Jul 12;2(7924):45-51. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolism (VTE)	Includes deep vein thrombosis (DVT) and pulmonary embolism (PE)	90 days following surgery
Secondary	Portal Thrombosis (PT)	Portal thrombosis	90 days following surgery
Secondary	Minor bleeding	Any bleeding that doesn't fulfill "major bleeding" criteria.	90 days following surgery
Secondary	Major bleeding	Any bleeding causing: death, serious threat to life, requirement of active medical intervention, 2 or more red blood cell units transfusion, localized in retroperitoneum, intracraneal or intraocular	90 days following surgery