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Periinterventional Coagulation Management of Patients Undergoing a TIPS

Key facts

Who runs it
Medical University of Graz
Where
Austria1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
39 people, planned
Started
27 May 2020
Expected to end
May 2028
Type of study
Interventional, 2 groups
Treatments tested
  • thrombelastogram
  • standard of care
Record updated
13 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Liver cirrhosis
  • >18 years
  • Indication for TIPS implantation
  • Ability to sign informed consent exclusion criteria
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Thrombelastogram (TEG)Treatment being tested

    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.

    Treatment: thrombelastogram

  • Standard of Care (SOC)Treatment being tested

    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

    Treatment: standard of care

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Optimizing Periinterventional Coagulation Management of Patients Undergoing a Transjugular Intrahepatic Portosystemic Shunt Implantation: A Prospective Randomized Cohort Study
Record updated
13 October 2026