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Periinterventional Coagulation Management of Patients Undergoing a TIPS

ConditionLiver Cirrhosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Graz

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Liver cirrhosis

>18 years

Indication for TIPS implantation

Ability to sign informed consent

Disqualifiers

Contraindications against TIPS implantation

Hepatocellular carcinoma BCLC D

Ongoing bleeding

pre-existing anticoagulant therapy at time of inclusion

Trial design

Design model

Parallel

Treatments tested in this trial

  • thrombelastogram

    Procedure/Surgery

    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

  • standard of care

    Procedure/Surgery

    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

Treatment groups

39 Participants
are divided into 2 treatment groups
Group A: Thrombelastogram (TEG)Experimental treatment 1 intervention
Group B: Standard of Care (SOC)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

blood product requirement

Amount of blood products (coagulation factors and platelet transfusions) transfused for pre-interventional correction of coagulation status

Time frame
2 days

Secondary outcomes

1

Bleeding

Rate of bleeding complications (BARC criteria)

Time frame
90 days
2

complications

Rate of transfusion related complications

Time frame
90 days
3

Mortality

Mortality rate

Time frame
90 days
4

Modified TIPS Score (MOTS)

Predictive power of modified TIPS score (MOTS) using the routine parameter, bilirubin, urea and INR; values range from 0-3, high score means worse outcome

Time frame
90 days

Other outcomes

Sponsors and contacts

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Medical University of Graz

Lead sponsor

Source ClinicalTrials.gov
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