Managing blood clotting in patients with liver cirrhosis undergoing TIPS
Optimizing Periinterventional Coagulation Management of Patients Undergoing a Transjugular Intrahepatic Portosystemic Shunt Implantation: A Prospective Randomized Cohort Study
This study is testing a new way to manage blood clotting in patients with liver cirrhosis who are having a TIPS procedure to see if it can help reduce complications and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Trial ID | NCT04421924 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of a thrombelastography-guided algorithm for managing coagulation status in patients with liver cirrhosis who are undergoing a transjugular intrahepatic portosystemic shunt (TIPS) procedure. The TIPS procedure is used to treat complications of portal hypertension in cirrhotic patients, but it carries risks such as bleeding and other complications due to coagulation disturbances. By optimizing coagulation management before the procedure, the study aims to reduce these risks and improve patient outcomes. Participants will be monitored for complications and overall health following the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 with liver cirrhosis who require TIPS implantation.
Not a fit: Patients with contraindications to TIPS, ongoing bleeding, or severe hepatic encephalopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications and mortality associated with TIPS in cirrhotic patients.
How similar studies have performed: While there have been studies on coagulation management in liver disease, this specific approach using thrombelastography is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
inclusion criteria * Liver cirrhosis * \>18 years * Indication for TIPS implantation * Ability to sign informed consent exclusion criteria * Contraindications against TIPS implantation * Hepatocellular carcinoma BCLC D * Ongoing bleeding * pre-existing anticoagulant therapy at time of inclusion * administration of blood products within 1 week prior to the enrolment * Other malignancies that lead to an impaired 90-day survival * Inherit blood clotting disorders * Hepatic encephalopathy grade 3 or 4 * any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol
Where this trial is running
Graz
- Department of Internal Medicine, Medical University of Graz — Graz, Austria (Recruiting)
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.