Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant

Liver Cirrhosis Clinical Trial

Official title:

Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02239991
• Other study ID #: 1986-14
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2014
• Last updated: September 15, 2014
• Start date: September 2014
• Est. completion date: February 2016

Study information

• Verified date: September 2014
• Source: Hospital Israelita Albert Einstein
• Contact: Luiz Henrique Ide Yamauchi, physician
• Phone: +55112151-7806
• Email: luizyamauchi[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

A point-of-care bleeding management protocol based on global viscoelastic test (thromboelastometry) can change the amount of blood products used during orthotopic liver transplant.

Description:

Patients with liver disease frequently acquire a complex disorder of hemostasis secondary to their disease.

The fundamental key to the management of coagulopathy of cirrhotic patient is the knowledge that hepatic dysfunction results in impairment of both pro-hemostatic factors as anti-hemostatic factors in a disproportionate manner which can lead to a clinical picture of both bleeding and thrombosis.

Routine tests of coagulation as prothrombin time (PT, INR) and activated partial thromboplastin time (APTT) although prolonged in cirrhotic patients cannot predict bleeding.

Global viscoelastic test of whole blood (TEG / ROTEM) produce a dynamic composite image of the entire coagulation process and have the potential to provide clinically relevant information in patients with liver disease allowing rational use of blood products during liver transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients from the national list of liver transplant assigned to have their transplant in Hospital Israelita Albert Einstein who gave free and clarified consent term.

Exclusion Criteria:

• acute liver failure

• age under 18

• combined transplant

• re transplantation less than 30 days

• incomplete medical records, more than 20% of missing data.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Evidence of Liver Transplantation
• Hemostatic Disorders
• Liver Cirrhosis

Intervention

Procedure:
• Thromboelastometry
Group of cirrhotic bleeding patients that are treated with a bed side, point of care protocol based on thromboelastometry to guide transfusion and manage coagulopathy

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	Sao Paulo	SP
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (27)

Agarwal A, Sharma N, Vij V. Point-of-care coagulation monitoring during liver transplantation. Trends in Anaesth and Crit Care. 2013;3:42-48.

Bauters A, Mazoyer E. Apport de la thromboe ´lastome ´trie rotative (ROTEM) pour l'exploration de l'he ´mostase: inte ´reˆt en pratique clinique. Revue francophone des laboratoires 2007; 393: 45-50

Blasi A, Beltran J, Pereira A, Martinez-Palli G, Torrents A, Balust J, Zavala E, Taura P, Garcia-Valdecasas JC. An assessment of thromboelastometry to monitor blood coagulation and guide transfusion support in liver transplantation. Transfusion. 2012 Sep;52(9):1989-98. doi: 10.1111/j.1537-2995.2011.03526.x. Epub 2012 Feb 5. — View Citation

Cacciarelli TV, Keeffe EB, Moore DH, Burns W, Busque S, Concepcion W, So SK, Esquivel CO. Effect of intraoperative blood transfusion on patient outcome in hepatic transplantation. Arch Surg. 1999 Jan;134(1):25-9. — View Citation

Davenport R, Khan S. Management of major trauma haemorrhage: treatment priorities and controversies. Br J Haematol. 2011 Dec;155(5):537-48. doi: 10.1111/j.1365-2141.2011.08885.x. Epub 2011 Oct 21. Review. — View Citation

de Boer MT, Christensen MC, Asmussen M, van der Hilst CS, Hendriks HG, Slooff MJ, Porte RJ. The impact of intraoperative transfusion of platelets and red blood cells on survival after liver transplantation. Anesth Analg. 2008 Jan;106(1):32-44, table of contents. doi: 10.1213/01.ane.0000289638.26666.ed. — View Citation

Ganter MT, Hofer CK. Coagulation monitoring: current techniques and clinical use of viscoelastic point-of-care coagulation devices. Anesth Analg. 2008 May;106(5):1366-75. doi: 10.1213/ane.0b013e318168b367. Review. — View Citation

Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. First of two parts--blood transfusion. N Engl J Med. 1999 Feb 11;340(6):438-47. Review. — View Citation

Goodnough LT, Brecher ME, Kanter MH, AuBuchon JP. Transfusion medicine. Second of two parts--blood conservation. N Engl J Med. 1999 Feb 18;340(7):525-33. Review. — View Citation

Kang YG, Martin DJ, Marquez J, Lewis JH, Bontempo FA, Shaw BW Jr, Starzl TE, Winter PM. Intraoperative changes in blood coagulation and thrombelastographic monitoring in liver transplantation. Anesth Analg. 1985 Sep;64(9):888-96. — View Citation

Liu LL, Niemann CU. Intraoperative management of liver transplant patients. Transplant Rev (Orlando). 2011 Jul;25(3):124-9. doi: 10.1016/j.trre.2010.10.006. Epub 2011 Apr 21. Review. — View Citation

Liu S, Fan J, Wang X, Gong Z, Wang S, Huang L, Xing T, Li T, Peng Z, Sun X. Intraoperative cryoprecipitate transfusion and its association with the incidence of biliary complications after liver transplantation--a retrospective cohort study. PLoS One. 2013 May 10;8(5):e60727. doi: 10.1371/journal.pone.0060727. Print 2013. — View Citation

Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. Review. — View Citation

Massicotte L, Sassine MP, Lenis S, Roy A. Transfusion predictors in liver transplant. Anesth Analg. 2004 May;98(5):1245-51, table of contents. — View Citation

Maxwell MJ, Wilson MJA. Complications of blood transfusion. Continuing Education in Anaesthesia. Crit Care Pain 2006; 6: 225-229

McCluskey SA, Karkouti K, Wijeysundera DN, Kakizawa K, Ghannam M, Hamdy A, Grant D, Levy G. Derivation of a risk index for the prediction of massive blood transfusion in liver transplantation. Liver Transpl. 2006 Nov;12(11):1584-93. — View Citation

Ozier Y, Pessione F, Samain E, Courtois F; French Study Group on Blood Transfusion in Liver Transplantation. Institutional variability in transfusion practice for liver transplantation. Anesth Analg. 2003 Sep;97(3):671-9. — View Citation

Ramos E, Dalmau A, Sabate A, Lama C, Llado L, Figueras J, Jaurrieta E. Intraoperative red blood cell transfusion in liver transplantation: influence on patient outcome, prediction of requirements, and measures to reduce them. Liver Transpl. 2003 Dec;9(12):1320-7. — View Citation

Rana A, Petrowsky H, Hong JC, Agopian VG, Kaldas FM, Farmer D, Yersiz H, Hiatt JR, Busuttil RW. Blood transfusion requirement during liver transplantation is an important risk factor for mortality. J Am Coll Surg. 2013 May;216(5):902-7. doi: 10.1016/j.jamcollsurg.2012.12.047. Epub 2013 Mar 9. — View Citation

Romero FA, Razonable RR. Infections in liver transplant recipients. World J Hepatol. 2011 Apr 27;3(4):83-92. doi: 10.4254/wjh.v3.i4.83. — View Citation

Saner FH, Gieseler RK, Akiz H, Canbay A, Görlinger K. Delicate balance of bleeding and thrombosis in end-stage liver disease and liver transplantation. Digestion. 2013;88(3):135-44. doi: 10.1159/000354400. Epub 2013 Sep 5. Review. — View Citation

Spahn DR, Casutt M. Eliminating blood transfusions: new aspects and perspectives. Anesthesiology. 2000 Jul;93(1):242-55. Review. — View Citation

Tanaka KA, Bader SO, Görlinger K. Novel approaches in management of perioperative coagulopathy. Curr Opin Anaesthesiol. 2014 Feb;27(1):72-80. doi: 10.1097/ACO.0000000000000025. Review. — View Citation

Tanaka KA, Bolliger D, Vadlamudi R, Nimmo A. Rotational thromboelastometry (ROTEM)-based coagulation management in cardiac surgery and major trauma. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1083-93. doi: 10.1053/j.jvca.2012.06.015. Epub 2012 Aug 3. Review. — View Citation

Tripodi A, Salerno F, Chantarangkul V, Clerici M, Cazzaniga M, Primignani M, Mannuccio Mannucci P. Evidence of normal thrombin generation in cirrhosis despite abnormal conventional coagulation tests. Hepatology. 2005 Mar;41(3):553-8. — View Citation

Trzebicki J, Flakiewicz E, Kosieradzki M, Blaszczyk B, Kolacz M, Jureczko L, Pacholczyk M, Chmura A, Lagiewska B, Lisik W, Wasiak D, Kosson D, Kwiatkowski A, Lazowski T. The use of thromboelastometry in the assessment of hemostasis during orthotopic liver transplantation reduces the demand for blood products. Ann Transplant. 2010 Jul-Sep;15(3):19-24. — View Citation

Weber CF, Görlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Units of packed red blood cells (PRBCs)	A prospective cohort study based on a point-of care protocol to monitor and manage the coagulopathy based on rotational thromboelastometry (ROTEM) in liver transplant with a historical control. Fifty patients will be managed by ROTEM protocol and will be compared with an equal number of historical controls treated according to the traditional protocol based on clinical and laboratory tests. The aim of this prospective study is to show a reduction in 20% of PRBCs transfusion during liver transplant.	intraoperative	Yes
Secondary	mortality	All patients in interventional group will be followed for a period of 30 days.	30 days	No
Secondary	Sepsis	Sepsis is defined as the presence (probable or documented) of infection together with systemic manifestations of infection. All patients in interventional group will be followed for a period of 30 days.	During intensive care unit	No
Secondary	Acute respiratory distress syndrome	A chest X-ray will be done in all patients and will be followed for a period of 30 days. A chest X-ray can reveal which parts of your lungs have fluid in them	During intensive care unit	No
Secondary	Mechanical ventilation	All patients in interventional group will be followed for a period of 30 days and will be noted the number of days under mechanical ventilation.	During intensive care unit	No
Secondary	Intensive care unit	Length of intensive care unit stay	up to 30 days	No