Periinterventional Coagulation Management of Patients Undergoing a TIPS

NCT04421924 | Recruiting

• 1 other identifier: TIPS-prospective
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• blood product requirement

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

  2 days

Secondary Outcomes (5)

• Bleeding

  90 days

• complications

  90 days

• Mortality

  90 days

• Modified TIPS Score (MOTS)

  90 days

• Factor XIII

  2 days

Study Arms (2)

Thrombelastogram (TEG)

EXPERIMENTAL

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.

Procedure: thrombelastogram

Standard of Care (SOC)

EXPERIMENTAL

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

Procedure: standard of care

Interventions

thrombelastogram PROCEDURE

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

Thrombelastogram (TEG)

standard of care PROCEDURE

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

Standard of Care (SOC)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Contraindications against TIPS implantation
• Hepatocellular carcinoma BCLC D
• Ongoing bleeding
• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8010, Austria

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

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

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: May 27, 2020
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)