Substitution of coagulation factors and blood products in patients with liver cirrhosis - A pilot study

Substitution of coagulation factors and blood products in patients with liver cirrhosis - A pilot study - COUCH - Coagulation in Cirrhosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006870-22-AT

Enrollment

Registered

2022-09-13

Start date

2022-11-04

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis MedDRA version: 20.0 Level: LLT Classification code 10024667 Term: Liver cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Trade Name: - Cofact 500 IE (Prothya Biosolutions Netherlands B.V.) Product Name: Cofact 500 IE Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: PROTHROMBIN COM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - liver cirrhosis - elective micro wave ablation, radio frequency ablation, biopsy/puncture of the liver (percutaneous or transjugular), percutaneous transhepatic cholangiodrainage, transjugular intrahepatic portosystemic shunt - INR > 1,5 and/or PLT count =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - age < 18 years - patients unable to consent - clinical signs or history of bleeding - recent thromboembolic event - chronic kidney disease stage G4 or G5 according to KDIGO - pregnant or breast feeding women - not paused anticoagulant medication (except acteylsalicylic acid)

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to evaluate the influence of a restrictive use of coagulation products on bleeding complications after interventions of the liver in patients with liver cirrhosis. ;Secondary Objective: To evaluate: - Use of coagulation and blood products in the first three days after the intervention - Incidence of bleeding complications over a period of 28 days after the intervention - Correlation of bleeding complications with van Willebrand factor-, ROTEM- and thrombin generation-analysis at the time of the intervention - Incidence of transfusion related events and thromboembolic events over a period of 28 days after the intervention - 28 day bleeding- or thrombosis associated mortality - Overall mortality ;Primary end point(s): incidence of bleeding complications;Timepoint(s) of evaluation of this end point: 3 days after the intervention	—

Measure

Time frame

Main Objective: The main objective is to evaluate the influence of a restrictive use of coagulation products on bleeding complications after interventions of the liver in patients with liver cirrhosis. ;Secondary Objective: To evaluate: - Use of coagulation and blood products in the first three days after the intervention - Incidence of bleeding complications over a period of 28 days after the intervention - Correlation of bleeding complications with van Willebrand factor-, ROTEM- and thrombin generation-analysis at the time of the intervention - Incidence of transfusion related events and thromboembolic events over a period of 28 days after the intervention - 28 day bleeding- or thrombosis associated mortality - Overall mortality ;Primary end point(s): incidence of bleeding complications;Timepoint(s) of evaluation of this end point: 3 days after the intervention

—

Secondary

Measure	Time frame
Secondary end point(s): - Use of coagulation and blood products in the first three days after the intervention - Incidence of bleeding complications over a period of 28 days after the intervention - Correlation of bleeding complications with van Willebrand factor-, ROTEM- and thrombin generation-analysis at the time of the intervention - Incidence of transfusion related events and thromboembolic events over a period of 28 days after the intervention - 28 day bleeding- or thrombosis associated mortality - Overall mortality ;Timepoint(s) of evaluation of this end point: 28 days after the intervention	—

Measure

Time frame

Secondary end point(s): - Use of coagulation and blood products in the first three days after the intervention - Incidence of bleeding complications over a period of 28 days after the intervention - Correlation of bleeding complications with van Willebrand factor-, ROTEM- and thrombin generation-analysis at the time of the intervention - Incidence of transfusion related events and thromboembolic events over a period of 28 days after the intervention - 28 day bleeding- or thrombosis associated mortality - Overall mortality ;Timepoint(s) of evaluation of this end point: 28 days after the intervention

—

Countries

Austria

Contacts

Public ContactDepartment of Anaesthesia

Medical University of Vienna

armin.langauer@meduniwien.ac.at+43140400 41000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026