Liver CirrhosisPhase 4COUCHNCT05667805
Coagulation in Cirrhosis
A Phase 4 study testing Platelet Concentrate, Prothrombin Complex Concentrate and Restricitve Use in people with Liver Cirrhosis, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Platelet Concentrate, Prothrombin Complex Concentrate and Restricitve Use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- 19 Jan 2023to 1 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
General Hospital of the Medical University of Vienna
Vienna, 1090
David M Baron, MD
David M Baron, MD
About this study
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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Being tested
- Platelet Concentrate, Prothrombin Complex Concentrate, Restricitve Use
- Keywords
- Patient Blood Management, Platelet Concentrates, Transfusion, Coagulation
- Medical subject headings
- Liver Cirrhosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet ConcentrateDrug
Liberal use (standard treatment)
Prothrombin Complex ConcentrateDrug
Also called PPSB
Liberal use (standard treatment)
Restricitve UseOther
Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Platelet Concentrate; Drug: Prothrombin Complex Concentrate |
| Restrictive substitution of human prothrombin complex and/or thrombocytes | Experimental | No substitution of blood products described in the Active Comparator group. Receives: Other: Restricitve Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Bleeding
bleeding complication within 3 days after the intervention
Measured: 3 days
Secondary outcomes (5)
bleeding complication
bleeding complication within 28 days after the intervention
Measured: 28 days
thromboembolic events
Measured: 28 days
transfusion related complications
Measured: 28 days
28 day overall mortality
Measured: 28 days
28 day bleeding related mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start19 Jan 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David M Baron, MD, PhD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667805
- Sponsor's protocol ID
- 1144/2022
- Acronym
- COUCH
- Status last verified
- Jan 2025
- First submitted
- 16 Dec 2022
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation in Cirrhosis
- ClinicalTrials.gov ID
- NCT05667805
- Acronym / sponsor ID
- COUCH / 1144/2022
- Conditions
- Liver Cirrhosis
- Keywords
- Patient Blood Management, Platelet Concentrates, Transfusion, Coagulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal substitution of human prothrombin complex and/or platelet concentrates | Active comparator | Drug: Platelet Concentrate, Drug: Prothrombin Complex ConcentrateIf 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 |
| Restrictive substitution of human prothrombin complex and/or thrombocytes | Experimental | Other: Restricitve UseNo substitution of blood products described in the Active Comparator group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- Missing informed consent or inability to consent
- Age < 18 years
- Pregnancy or breastfeeding
- Manifest ascites
- Chronic kidney injury stage G4 or G5, KDIGO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet ConcentrateLiberal use (standard treatment) | Drug | Liberal substitution of human prothrombin complex and/or platelet concentrates |
| Prothrombin Complex ConcentrateAlso: PPSBLiberal use (standard treatment) | Drug | Liberal substitution of human prothrombin complex and/or platelet concentrates |
| Restricitve UseRestrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution. | Other | Restrictive substitution of human prothrombin complex and/or thrombocytes |
Primary outcome
Major Bleeding
Time frame: 3 days
bleeding complication within 3 days after the intervention
5 secondary outcomes
bleeding complication
Time frame: 28 days
thromboembolic events
Time frame: 28 days
transfusion related complications
Time frame: 28 days
28 day overall mortality
Time frame: 28 days
28 day bleeding related mortality
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet Concentrate, Prothrombin Complex Concentrate and Restricitve Use in people with Liver Cirrhosis, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armin Langauer, MD (+43 1 40400 41000, armin.langauer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Bleeding (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.