Evaluating blood clotting in patients with liver cirrhosis and cancer
Novel Biomarkers for Evaluation of Hemostasis and Inflammation in Liver Cirrhosis
This study is testing new ways to check blood clotting in patients with liver cirrhosis and cancer to see how their condition affects bleeding and clotting risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm, Huddinge) |
| Trial ID | NCT06212635 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on assessing hemostasis in patients with decompensated liver cirrhosis using novel hemostatic assays. It aims to understand the delicate balance of bleeding and thrombosis in these patients, who are at risk due to their condition. By comparing the hemostatic profiles of patients with healthy controls, the study seeks to identify effective methods for evaluating hemostasis in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with decompensated liver cirrhosis.
Not a fit: Patients with extrahepatic malignancies, certain coagulation disorders, or those who have undergone liver transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment and management of bleeding and clotting risks in patients with liver cirrhosis.
How similar studies have performed: While there is ongoing research in this area, the use of novel hemostatic assays for evaluating hemostasis in liver cirrhosis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with decompensated liver cirrhosis * 18 years or older. * Healthy individuals 18 years or older will serve as controls. Exclusion Criteria: * • Extrahepatic malignancy or recurrence of such within the last year. * Diagnosis of non-cirrhotic coagulopathy, coagulation disorder or thrombophilia prior to inclusion. * Diagnosis of hematological disease such as hematologic malignancies, non-cirrhotic thrombocytopenia or thrombocytosis, Polycytemia Vera, hemoglobinopathies * Previous liver transplantation. * Transfusions the last 7 days. * Treatment with platelet inhibitors or anticoagulant except for prophylactic dosage of LMWH. If a prophylactic dose of LMWH has been used study sampling with addition of antiFXa must be taken \>12 hours after the last injection.
Where this trial is running
Stockholm, Huddinge
- Karolinska University Hospital — Stockholm, Huddinge, Sweden (Recruiting)
Study contacts
- Principal investigator: Maria Magnusson, MD, PhD — Region Stockholm, Karolinska Institute
- Study coordinator: Sanna Norén, MD, PhDstudent
- Email: sanna.noren@regionstockholm.se
- Phone: +46703131799
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.