Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Historical control | No Intervention | Group of patients that had their coagulopathy secondary to the liver transplant treated based on conventional laboratory tests. Before the implementation of thromboelastometry. | |
| Intervention | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thromboelastometry | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | All patients in interventional group will be followed for a period of 30 days. | 30 days |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luiz Henrique Ide Yamauchi, physician | Contact | +55112151-7806 | luizyamauchi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luiz Henrique Ide Yamauchi, Physician | Hospital Israelita Albert Einstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | Active, not recruiting | São Paulo | São Paulo | 05652-000 | Brazil | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23478547 | Background | 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. | |
| Background | Maxwell MJ, Wilson MJA. Complications of blood transfusion. Continuing Education in Anaesthesia. Crit Care Pain 2006; 6: 225-229 | ||
| 15105195 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D008103 | Liver Cirrhosis |
| D058625 | End Stage Liver Disease |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013916 | Thrombelastography |
| ID | Term |
|---|---|
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| During intensive care unit |
| 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 |
| 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 |
| Intensive care unit | Length of intensive care unit stay | up to 30 days |
| Hospital Israelita Albert Einstein |
| Recruiting |
| São Paulo |
| São Paulo |
| 05652-900 |
| Brazil |
|
| Background |
| Massicotte L, Sassine MP, Lenis S, Roy A. Transfusion predictors in liver transplant. Anesth Analg. 2004 May;98(5):1245-51, table of contents. doi: 10.1213/01.ane.0000111184.21278.07. |
| 21514137 | Background | 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. |
| 12933381 | Background | 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):671-679. doi: 10.1213/01.ANE.0000073354.38695.7C. |
| 18165548 | Background | 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. |
| 23675406 | Background | 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. |
|
| 14625833 | Background | 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. doi: 10.1016/jlts.2003.50204. |
| 9927126 | Background | 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. doi: 10.1001/archsurg.134.1.25. |
| 9971869 | Background | 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. doi: 10.1056/NEJM199902113400606. No abstract available. |
| 10021474 | Background | 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. doi: 10.1056/NEJM199902183400706. No abstract available. |
| 10861168 | Background | Spahn DR, Casutt M. Eliminating blood transfusions: new aspects and perspectives. Anesthesiology. 2000 Jul;93(1):242-55. doi: 10.1097/00000542-200007000-00035. No abstract available. |
| 22914710 | Background | Weber CF, Gorlinger 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. doi: 10.1097/ALN.0b013e318264c644. |
| 22017416 | Background | 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. |
| 24008288 | Background | Saner FH, Gieseler RK, Akiz H, Canbay A, Gorlinger 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. |
| 15726661 | Background | 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. doi: 10.1002/hep.20569. |
| 3896028 | Background | 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. |
| 20877262 | Background | 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. |
| Background | Agarwal A, Sharma N, Vij V. Point-of-care coagulation monitoring during liver transplantation. Trends in Anaesth and Crit Care. 2013;3:42-48. |
| 22304465 | Background | 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. |
| 16952177 | Background | 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. doi: 10.1002/lt.20868. |
| 18420846 | Background | 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. |
| Background | 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 |
| 15784122 | Background | Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x. |
| 24263685 | Background | Tanaka KA, Bader SO, Gorlinger K. Novel approaches in management of perioperative coagulopathy. Curr Opin Anaesthesiol. 2014 Feb;27(1):72-80. doi: 10.1097/ACO.0000000000000025. |
| 22863406 | Background | 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. No abstract available. |
| 21603030 | Background | 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. |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |