Management of Coagulopathy in Cirrhotic Patients Undergoing Invasive Procedures

NCT02987712 | Unknown

• 1 other identifier: TASMC-16-IM-0703-CTIL
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Recently it has been acknowledged that cirrhotic patients present with "rebalanced hemostasis" that results from decreased levels of both pro-coagulant and anti-coagulant factors, that is not well reflected by conventional coagulation tests (CCTs). Thromboelastography (TEG) might be a more accurate tool in these patients. Numerous guidelines on the management of the cirrhotic patient undergoing invasive procedures have been published but most of them are not evidence based. Current literature, although conflicting, is leaning towards a restrictive approach to prophylactic correction of coagulopathy when performing invasive procedures in cirrhotic patients. The investigators suspect that common practice is more liberal . Considering the well-known adverse effects of blood product administration, the aim of the study is to re-evaluate the clinical management of cirrhotic patients undergoing invasive procedures. Study objectives: asserting whether the use of blood products prior to invasive procedures in cirrhotic coagulopathic patients can be reduced using TEG to evaluate coagulopathy in place of CCTs, evaluating the rate of complications due to blood product use, and checking how well CCT results correlate with TEG results in these patients. This will be a prospective pre/post TEG protocol implementation study which will include two prospective surveys with a 1:1 ratio. Survey 1: prophylactic administration of FFP/PLT prior to minor invasive procedures will be based on CCTs and physicians' clinical judgement. Survey 2: management will be based on a new TEG protocol. The investigators will include cirrhotic patients with coagulopathy who are candidates for an invasive procedure. Subject will be provided with sufficient time to reach a rational, informed decision regarding participation in the study. Data will be collected from the computer based medical record systems, the patient file and directly from the caring physician and will include a thorough medical history and conventional blood tests, including a TEG test. All subjects will be managed according to standard of care. Primary endpoint: amount of blood product (fresh frozen plasma/platelets) units transfused in preparation for the invasive procedures. Secondary endpoints: bleeding complications, transfusion related side effects, 90 day survival and other complications. This will be a prospective (pre/post) study. The calculated sample size needed is 120 subjects, 60 in each group.

Conditions

Liver Cirrhosis; Coagulopathy

Keywords

Thromboelastography

Outcome Measures

Primary Outcomes (1)

• Amount of blood product (FFP/PLT) units transfused in preparation for the invasive procedures.

  Number of FFP/PLT units transfused

  Intraoperative

Secondary Outcomes (4)

• Bleeding complications.

  up to 30 days from procedure performance or death, whichever comes first

• Transfusion-related side effects

  up to 30 days from procedure performance or death, whichever comes first

• 90-day survival

  Up to 90 days from procedure performance

• Other complications

  up to 30 days from procedure performance or death, whichever comes first

Study Arms (2)

Survey 1

NO INTERVENTION

Common practice

Survey 2

EXPERIMENTAL

Thromboelastography based protocol

Other: Thromboelastography based protocol

Interventions

Thromboelastography based protocol OTHER

patients will be treated according to a new thromboelastography based protocol

Survey 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Follow up at the Gastroenterology Unit at TLVMC
• Diagnosis of cirrhosis
• Abnormal coagulation test results: INR \> 1.5 and/or a PLT count \< 50x10\^9/L
• Planned to undergo an invasive procedure
• Hospitalization in one of the following units at TLVMC: Internal Medicine D, Internal Medicine T, Internal Medicine Consultations, Intensive Care Unit, Surgical Intensive Care Unit, General Surgery Division and the Gastroenterology unit.
• Invasive procedures: central venous catheter placement, drainage of ascitic fluid, endoscopic procedures (variceal ligation or polypectomy) or any surgical procedure (excluding liver transplantation).

You may not qualify if:

• Ongoing bleeding
• Current/recent (past 7 days) antiplatelet/anticoagulant therapy
• Hemodialysis in the previous 7 days.
• planned procedure is liver transplantation.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Related Publications (16)

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  PMID: 24721432 BACKGROUND

• Tripodi A, Mannucci PM. The coagulopathy of chronic liver disease. N Engl J Med. 2011 Jul 14;365(2):147-56. doi: 10.1056/NEJMra1011170. No abstract available.

  PMID: 21751907 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.

  PMID: 15726661 BACKGROUND

• Salooja N, Perry DJ. Thrombelastography. Blood Coagul Fibrinolysis. 2001 Jul;12(5):327-37. doi: 10.1097/00001721-200107000-00001.

  PMID: 11505075 BACKGROUND

• Mallett SV, Chowdary P, Burroughs AK. Clinical utility of viscoelastic tests of coagulation in patients with liver disease. Liver Int. 2013 Aug;33(7):961-74. doi: 10.1111/liv.12158. Epub 2013 May 3.

  PMID: 23638693 BACKGROUND

• European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available.

  PMID: 20633946 BACKGROUND

• Runyon BA; AASLD Practice Guidelines Committee. Management of adult patients with ascites due to cirrhosis: an update. Hepatology. 2009 Jun;49(6):2087-107. doi: 10.1002/hep.22853. No abstract available.

  PMID: 19475696 BACKGROUND

• Northup PG, Caldwell SH. Coagulation in liver disease: a guide for the clinician. Clin Gastroenterol Hepatol. 2013 Sep;11(9):1064-74. doi: 10.1016/j.cgh.2013.02.026. Epub 2013 Mar 16.

  PMID: 23506859 BACKGROUND

• Patel IJ, Davidson JC, Nikolic B, Salazar GM, Schwartzberg MS, Walker TG, Saad WA; Standards of Practice Committee, with Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Endorsement. Consensus guidelines for periprocedural management of coagulation status and hemostasis risk in percutaneous image-guided interventions. J Vasc Interv Radiol. 2012 Jun;23(6):727-36. doi: 10.1016/j.jvir.2012.02.012. Epub 2012 Apr 17. No abstract available.

  PMID: 22513394 BACKGROUND

• Baron RM. Point: should coagulopathy be repaired prior to central venous line insertion? Yes: why take chances? Chest. 2012 May;141(5):1139-1142. doi: 10.1378/chest.11-3225. No abstract available.

  PMID: 22553259 BACKGROUND

• Singh SA, Sharma S, Singh A, Singh AK, Sharma U, Bhadoria AS. The safety of ultrasound guided central venous cannulation in patients with liver disease. Saudi J Anaesth. 2015 Apr-Jun;9(2):155-60. doi: 10.4103/1658-354X.152842.

  PMID: 25829903 BACKGROUND

• Lopez-Delgado JC, Ballus J, Esteve F, Betancur-Zambrano NL, Corral-Velez V, Manez R, Betbese AJ, Roncal JA, Javierre C. Outcomes of abdominal surgery in patients with liver cirrhosis. World J Gastroenterol. 2016 Mar 7;22(9):2657-67. doi: 10.3748/wjg.v22.i9.2657.

  PMID: 26973406 BACKGROUND

• Yates SG, Gavva C, Agrawal D, Sarode R. How do we transfuse blood components in cirrhotic patients undergoing gastrointestinal procedures? Transfusion. 2016 Apr;56(4):791-8. doi: 10.1111/trf.13495. Epub 2016 Feb 15.

  PMID: 26876945 BACKGROUND

• De Pietri L, Bianchini M, Montalti R, De Maria N, Di Maira T, Begliomini B, Gerunda GE, di Benedetto F, Garcia-Tsao G, Villa E. Thrombelastography-guided blood product use before invasive procedures in cirrhosis with severe coagulopathy: A randomized, controlled trial. Hepatology. 2016 Feb;63(2):566-73. doi: 10.1002/hep.28148. Epub 2015 Dec 9.

  PMID: 26340411 BACKGROUND

• Coakley M, Reddy K, Mackie I, Mallett S. Transfusion triggers in orthotopic liver transplantation: a comparison of the thromboelastometry analyzer, the thromboelastogram, and conventional coagulation tests. J Cardiothorac Vasc Anesth. 2006 Aug;20(4):548-53. doi: 10.1053/j.jvca.2006.01.016. Epub 2006 Apr 19.

  PMID: 16884987 BACKGROUND

• Wang SC, Shieh JF, Chang KY, Chu YC, Liu CS, Loong CC, Chan KH, Mandell S, Tsou MY. Thromboelastography-guided transfusion decreases intraoperative blood transfusion during orthotopic liver transplantation: randomized clinical trial. Transplant Proc. 2010 Sep;42(7):2590-3. doi: 10.1016/j.transproceed.2010.05.144.

  PMID: 20832550 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Idit Matot, MD, PhD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idit Matot, MD, PhD

CONTACT

97236974758; iditm@tlvmc.gov.il

Miri Davidovich

CONTACT

97236974758; mirid@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share