Coagulation Disorder, Liver Cirrhosis
Conditions
Brief summary
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG as a guide for blood products transfusion in cirrhotic patients undergoing invasive procedures.
Interventions
PROCEDUREThromboelastography to guide blood products infusion
A TEG has been performed before invasive procedure and blood products infusion has been decided according to TEG parameters as follow: fresh frozen plasma (FFP 10 ml/kg) in case of r time\>40 mm and/or platelets (PLTs 10 units/Kg) for MA\<30 mm
PROCEDUREStandard of care coagulation tests to guide blood products infusion
Patients received FFP (10 ml/kg) if INR\>1.8 and/or PLTS (10 units/Kg) If PLTs count \< 50000/μl
Sponsors
University of Modena and Reggio Emilia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologic or imaging-proven liver cirrhosis of any etiology * INR\>1.8 and/or PLTs count \<50x103/μl
Exclusion criteria
* Ongoing bleeding * Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel * Ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study * Presence of sepsis according to ACP-SCCP criteria * Hemodialysis performed within 7 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison in the amount of blood products transfused between the groups | 48 hours from admission | Comparison of the number of patients receiving blood products (FFPor PLTs or both), and the amount of blood products between the study groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-procedure bleeding | 48 hours from admission | Comparison of the number of patients having bleeding episodes after procedure between the study groups |
| Survival | 90 days patient survival | Comparison of patients survival between the study groups |
| Transfusion related side effects | 48 hours from admission | Comparison of the number of patients presenting transfusion side effects between the study groups |
| Procedure-related complications | during hospitalization (mean 4 weeks) | Comparison of the number of patients presenting post-procedures complication other than bleeding between the study groups |
| Comparison between blood products costs between groups | 48 hours from admission | — |
Outcome results
None listed