COUCH: Coagulation in Cirrhosis

Sponsor

Medical University of Vienna (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05667805

Collaborator

(none)

400

Enrollment

Arms

49.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Out of fear of bleeding, liver cirrhosis patients are often treated prophylactically with blood and coagulation products before minor interventions. The COUCH study will examine whether these patients benefit from a restrictive administration of coagulation products.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis	Drug: Platelet Concentrate Drug: Prothrombin Complex Concentrate Other: Restricitve Use	Phase 4

Detailed Description

Patients with cirrhosis commonly have deranged coagulation parameters, in particular thrombocytopenia and/or an increased INR. However, these laboratory findings do not necessarily correlate with an increased tendency of bleeding. In fact, the reduced synthesis of both pro- and anticoagulant factors often equates to a new equilibrium in the coagulation system. Nevertheless, out of fear of bleeding, liver cirrhosis patients with deviated laboratory coagulation parameters are often aggressively treated with coagulation products (such as platelet concentrates and prothrombin complex concentrate (PCC)) before minor interventions and punctures. Since these products can also have procoagulant side effects, we will investigate whether patients with liver cirrhosis without a history of bleeding or clinical bleeding signs benefit from a restrictive substitution regime. The study will be carried out monocentrically at the General Hospital of Vienna, and will include 400 patients divided into two groups (liberal vs. restrictive substitution of thrombocytes and/or PCC) over an est. period of 4 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

interventional radiologists

Primary Purpose:

Treatment

Official Title:

Coagulation in Cirrhosis

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Mar 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Liberal substitution of human prothrombin complex and/or platelet concentrates If INR < 1,5: 10 I.E. human prothrombin complex/kg bodyweigt/0,5 INR AND/OR If platelets < 50 G/l: ((50 G/l - measured thrombocyte concentration G/l) x total blood volume) platelet concentrate	Drug: Platelet Concentrate Liberal use (standard treatment) Drug: Prothrombin Complex Concentrate Liberal use (standard treatment) Other Names: PPSB
Experimental: Restrictive substitution of human prothrombin complex and/or thrombocytes No substitution of blood products described in the Active Comparator group.	Other: Restricitve Use Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.

Arm

Intervention/Treatment

Active Comparator: Liberal substitution of human prothrombin complex and/or platelet concentrates

If INR < 1,5: 10 I.E. human prothrombin complex/kg bodyweigt/0,5 INR AND/OR If platelets < 50 G/l: ((50 G/l - measured thrombocyte concentration G/l) x total blood volume) platelet concentrate

Drug: Platelet Concentrate

Liberal use (standard treatment)

Drug: Prothrombin Complex Concentrate

Liberal use (standard treatment)

Other Names:

PPSB

Experimental: Restrictive substitution of human prothrombin complex and/or thrombocytes

No substitution of blood products described in the Active Comparator group.

Other: Restricitve Use

Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.

Outcome Measures

Primary Outcome Measures

Major Bleeding [3 days]
bleeding complication within 3 days after the intervention

Secondary Outcome Measures

bleeding complication [28 days]
bleeding complication within 28 days after the intervention
thromboembolic events [28 days]
transfusion related complications [28 days]
28 day overall mortality [28 days]
28 day bleeding related mortality [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients at the University Hospital of Vienna with diagnosed liver cirrhosis and deranged coagulation parameters (INR >1,5 AND/ OR platelet count <50 G/L) who are scheduled for one of the following elective invasive interventions of the liver

Biopsy or puncture
Microwave ablation (MWA) or radiofrequency ablation (RFA)
Transjugular intrahepatic portosystemic shunt (TIPS)
Percutaneous transhepatic cholangiography drain (PTCD)

Exclusion Criteria:

Missing informed consent or inability to consent
Age < 18 years
Pregnancy or breastfeeding
Manifest ascites
Chronic kidney injury stage G4 or G5, KDIGO
Uninterrupted anticoagulant therapy, except for acetylsalicylic acid (ASA)
History of bleeding or clinical signs of a hemorrhagic diathesis in the physical examination (e.g., petechia, ecchymosis, mucosal bleeding, hemorrhagic diathesis within the family, menorrhagia, prolonged bleeding after surgery)