Investigating blood product use in liver cirrhosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines whether patients with liver cirrhosis benefit from a restrictive approach to administering blood and coagulation products before minor interventions. It focuses on patients who have deranged coagulation parameters but no history of bleeding. The trial will involve 400 patients at the General Hospital of Vienna, divided into two groups: one receiving liberal treatment and the other receiving a restrictive treatment regimen. The goal is to determine if a more conservative approach can be effective and safe for these patients.

Why it matters

Who can join: the full rules

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)

Where it's running

• General Hospital of the Medical University of Vienna
  Vienna, Austria Recruiting

Study contacts

• Study coordinator: Armin Langauer, MD
• Email: armin.langauer@meduniwien.ac.at
• Phone: +43 1 40400 41000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.