NCT05667805

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
10mo left

Started Jan 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jan 2023Mar 2027

First Submitted

Initial submission to the registry

December 16, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 29, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

January 19, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

4 years

First QC Date

December 16, 2022

Last Update Submit

January 10, 2025

Conditions

Liver Cirrhosis

Keywords

Patient Blood ManagementPlatelet ConcentratesTransfusionCoagulation

Outcome Measures

Primary Outcomes (1)

  • Major Bleeding

    bleeding complication within 3 days after the intervention

    3 days

Secondary Outcomes (5)

  • bleeding complication

    28 days

  • thromboembolic events

    28 days

  • transfusion related complications

    28 days

  • 28 day overall mortality

    28 days

  • 28 day bleeding related mortality

    28 days

Study Arms (2)

Liberal substitution of human prothrombin complex and/or platelet concentrates

ACTIVE COMPARATOR

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 ConcentrateDrug: Prothrombin Complex Concentrate

Restrictive substitution of human prothrombin complex and/or thrombocytes

EXPERIMENTAL

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

Other: Restricitve Use

Interventions

Platelet ConcentrateDRUG

Liberal use (standard treatment)

Liberal substitution of human prothrombin complex and/or platelet concentrates
Prothrombin Complex ConcentrateDRUG

Liberal use (standard treatment)

Also known as: PPSB
Liberal substitution of human prothrombin complex and/or platelet concentrates
Restricitve UseOTHER

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

Restrictive substitution of human prothrombin complex and/or thrombocytes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of the Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisThrombosis

Interventions

Factor IXprothrombin complex concentrates

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Central Study Contacts

Armin Langauer, MD

CONTACT

+43 1 40400 41000armin.langauer@meduniwien.ac.at

Kristina Nieding, MD

CONTACT

+43 1 40400 41000kristina.nieding@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
interventional radiologists
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 16, 2022

First Posted

December 29, 2022

Study Start

January 19, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 14, 2025

Record last verified: 2025-01

Locations

AU(1)