Investigating blood product use in liver cirrhosis patients
Coagulation in Cirrhosis
PHASE4 · Medical University of Vienna · NCT05667805
This study tests if giving less blood and clotting products to patients with liver cirrhosis before minor procedures is safe and helpful compared to giving more.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna (other) |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05667805 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with diagnosed liver cirrhosis and specific coagulation abnormalities scheduled for elective invasive liver interventions.
Not a fit: Patients with a history of bleeding or clinical signs of hemorrhagic diathesis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce unnecessary blood product transfusions in liver cirrhosis patients, minimizing risks and costs.
How similar studies have performed: While similar studies have explored coagulation management in cirrhosis, this specific restrictive approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Vienna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Cirrhosis, Patient Blood Management, Platelet Concentrates, Transfusion, Coagulation