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Coagulation in Cirrhosis (COUCH)

Primary Purpose

Liver Cirrhosis

Status
Recruiting
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Platelet Concentrate
Prothrombin Complex Concentrate
Restricitve Use
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Patient Blood Management, Platelet Concentrates, Transfusion, Coagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • General Hospital of the Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Liberal substitution of human prothrombin complex and/or platelet concentrates

Restrictive substitution of human prothrombin complex and/or thrombocytes

Arm Description

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

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

Outcomes

Primary Outcome Measures

Major Bleeding
bleeding complication within 3 days after the intervention

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2022
Last Updated
March 15, 2023
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT05667805
Brief Title
Coagulation in Cirrhosis
Acronym
COUCH
Official Title
Coagulation in Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Patient Blood Management, Platelet Concentrates, Transfusion, Coagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
interventional radiologists
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liberal substitution of human prothrombin complex and/or platelet concentrates
Arm Type
Active Comparator
Arm Description
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
Arm Title
Restrictive substitution of human prothrombin complex and/or thrombocytes
Arm Type
Experimental
Arm Description
No substitution of blood products described in the Active Comparator group.
Intervention Type
Drug
Intervention Name(s)
Platelet Concentrate
Intervention Description
Liberal use (standard treatment)
Intervention Type
Drug
Intervention Name(s)
Prothrombin Complex Concentrate
Other Intervention Name(s)
PPSB
Intervention Description
Liberal use (standard treatment)
Intervention Type
Other
Intervention Name(s)
Restricitve Use
Intervention Description
Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.
Primary Outcome Measure Information:
Title
Major Bleeding
Description
bleeding complication within 3 days after the intervention
Time Frame
3 days
Secondary Outcome Measure Information:
Title
bleeding complication
Description
bleeding complication within 28 days after the intervention
Time Frame
28 days
Title
thromboembolic events
Time Frame
28 days
Title
transfusion related complications
Time Frame
28 days
Title
28 day overall mortality
Time Frame
28 days
Title
28 day bleeding related mortality
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Armin Langauer, MD
Phone
+43 1 40400 41000
Email
armin.langauer@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Nieding, MD
Phone
+43 1 40400 41000
Email
kristina.nieding@meduniwien.ac.at
Facility Information:
Facility Name
General Hospital of the Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David M Baron, MD
First Name & Middle Initial & Last Name & Degree
David M Baron, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Coagulation in Cirrhosis

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