Recruiting PHASE4 Liver Cirrhosis

New treatment option for Liver Cirrhosis

Official title Coagulation in Cirrhosis

ClinicalTrials.gov ID: NCT05667805

What this study is testing

What is Platelet Concentrate?

Platelet Concentrate is an investigational medicine, being studied as a potential treatment for liver cirrhosis.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Patients at the University Hospital of Vienna with diagnosed liver cirrhosis and deranged coagulation parameters (INR \>1,5 AND/ OR platelet count...
  • Biopsy or puncture
  • Microwave ablation (MWA) or radiofrequency ablation (RFA)
  • Transjugular intrahepatic portosystemic shunt (TIPS)
  • Percutaneous transhepatic cholangiography drain (PTCD)

You likely can't join 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)
See the full eligibility criteria
Who can 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...
  • Biopsy or puncture
  • Microwave ablation (MWA) or radiofrequency ablation (RFA)
  • Transjugular intrahepatic portosystemic shunt (TIPS)
  • Percutaneous transhepatic cholangiography drain (PTCD)
What rules you out
  • 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...

The study team makes the final eligibility decision.

Where it's taking place

  • Vienna, Austria

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.