RecruitingNot ApplicableNCT04421924

Periinterventional Coagulation Management of Patients Undergoing a TIPS

Optimizing Periinterventional Coagulation Management of Patients Undergoing a Transjugular Intrahepatic Portosystemic Shunt Implantation: A Prospective Randomized Cohort Study


Sponsor

Medical University of Graz

Enrollment

39 participants

Start Date

May 27, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Assess whether a pre-interventional thrombelastography guided algorithm for assessing and correction of coagulation status in cirrhotic patients is safe and effective


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Liver cirrhosis
  • \>18 years
  • Indication for TIPS implantation

Exclusion Criteria9

  • Contraindications against TIPS implantation
  • Hepatocellular carcinoma BCLC D
  • Ongoing bleeding
  • pre-existing anticoagulant therapy at time of inclusion
  • administration of blood products within 1 week prior to the enrolment
  • Other malignancies that lead to an impaired 90-day survival
  • Inherit blood clotting disorders
  • Hepatic encephalopathy grade 3 or 4
  • any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol

Interventions

PROCEDUREthrombelastogram

Patients in the TEG group will receive prothrombin complex concentrates (PCC) at a dose of 10 IE/kg of ideal body weight, when R-time was greater than 40 minutes (2400 sec) and they will receive platelet transfusion in the amount of 1 apheresis unit when MA was below 30 mm

PROCEDUREstandard of care

2\) In the SOC group, patients will receive PCC at the dose of 10 IE /kg of ideal body weight when the PT is below 50% and/or INR\>1.8 and/or received platelet transfusion in the amount of 1 apheresis when platelet count is below 50 G/L


Locations(1)

Department of Internal Medicine, Medical University of Graz

Graz, Austria

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NCT04421924


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