Liver Cirrhosis With Acute Decompensation
Conditions
Keywords
ROTEM, decompensated liver cirrhosis, bleeding risk, blood product transfusion
Brief summary
Patients with liver cirrhosis have historically received prophylactic transfusions before invasive procedures with high risk of bleeding. The optimal method for establishing the need of blood transfusion before invasive procedures in cirrhotic patients has not been determined yet, and there are not enough scientific data to warrant empirical transfusion. In many surgical and trauma-related contexts, viscoelastic tests, like Rotational Thromboelastometry (ROTEM), offer a comprehensive assessment of hemostasis, and it has been demonstrated to predict bleeding risk more accurately than traditional coagulation tests. The aim of this project is to evaluate the efficacy of a ROTEM-based algorithm in managing the administration of prophylactic blood components to patients diagnosed with decompensated liver cirrhosis undergoing invasive high risk of bleeding procedures. The investigators hypothesized that ROTEM-based decision-making will lead to a reduction in pre-procedural blood component usage, particularly fresh frozen plasma (FFP), compared with standard of care, whilst maintaining optimal clinical outcomes. The investigators will perform a prospective, single-center, randomized controlled clinical trial in a tertiary university hospital in Romania, comparing ROTEM-guided prophylactic blood component administration to standard of care in patients with decompensated cirrhosis and coagulopathy undergoing invasive procedures. Inclusion criteria: adults (aged 18 years or older) admitted with cirrhosis and an indication for high risk of bleeding invasive procedure defined as: transjugular liver biopsy, transjugular intrahepatic portosystemic shunt, endoscopic retrograde cholangio-pancreatography with sphincterotomy, endoscopic polypectomy of polyps more than 1 cm, variceal banding and complex dental extraction. The primary safety endpoint will be the incidence of major bleeding. Secondary endpoints will be the proportion of blood products transfusion, hospital length of stay, in-hospital and 28-day mortality, incidence of minor bleeding, transfusion related adverse reactions, and cost analysis.
Detailed description
This project will compare two blood transfusion protocols (coagulogram-based and thromboelastometry-based) prior to high risk of bleeding procedures in patients with cirrhosis. The investigators hypothesized that thromboelastometry-guided transfusion protocols are safe and would decrease the need of blood products transfusion compared to an ordinary coagulogram-based protocol in patients with decompensated cirrhosis receiving high risk of bleeding procedures.
Interventions
PROCEDUREBlood Products transfusion
Blood Products transfusion
Sponsors
Grigore T. Popa University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosed with decompensated liver cirrhosis of any etiology * planned for a high risk of bleeding invasive procedure * coagulopathic based on conventional coagulation tests and considered for pre-procedural blood component prophylaxis * able and willing to provide informed consent
Exclusion criteria
* acute liver failure * current use of anticoagulant treatment * patients on antiplatelet aggregation agents * patients who have received FFP, platelet transfusion, cryoprecipitate in the week prior to the procedure * patients with stage 4 or 5 chronic kidney disease or patients receiving renal replacement therapy * sepsis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients transfused with any blood product | From the enrollment to 30 days after the procedure | This measure represents the percentage of patients within the study population who received at least one transfusion of any blood component during study period. It is calculated by dividing the number of patients who were administered one or more units of a blood product by the total number of eligible patients in the cohort, and multiplying by 100 to express the result as a percentage. Blood products include platelets, fresh frozen plasma, or cryoprecipitate. |
| The incidence of major bleeding within the first 24 h | From the enrollment to 30 days after the procedure | The incidence of major bleeding within the first 24 h after high risk of bleeding invasive procedures. It quantifies early clinically significant hemorrhagic complications and is typically expressed as a percentage or rate. For the purposes of this measure, major bleeding is defined according to standardized clinical criteria. Commonly applied definitions include adapted criteria from the International Society on Thrombosis and Haemostasis (ISTH) or similar consensus frameworks. A bleeding event is classified as major if it meets one or more of the following conditions: fatal bleeding, symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, pericardial, or intramuscular with compartment syndrome), a decrease in hemoglobin of ≥2 g/dL (≥20 g/L) within 24 hours attributable to bleeding , transfusion of ≥2 units of packed red blood cells due to acute blood loss, bleeding requiring urgent procedural or surgical intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of acute transfusion-related adverse events | From enrollment to 30 days after the procedure | This measure represents the proportion of transfusion episodes that are complicated by an acute transfusion-related adverse event occurring during or within 24 hours after the administration of a blood component. It will be expressed as a percentage and it will be calculated by dividing the number of transfusion episodes complicated by at least one qualifying acute adverse event by the total number of transfusion episodes administered during the study period. An acute transfusion-related adverse event is defined as a new clinical sign or symptom occurring during transfusion or within 24 hours after completion, for which a causal relationship to the transfused blood component is suspected, probable, or definite. The investigators will evaluate transfusion-associated cardiac overload, acute hemolytic transfusion reactions, anaphylactic reactions, febrile non-hemolytic reactions and urticarial reactions. |
| The hospital length of stay | From enrollment to 30 days after the procedure | The investigators will evaluate the hospital length of stay in both study arms |
| In hospital mortality | From the enrollment to discharge or death | This measure represents the proportion of patients who die from any cause during hospital admission. It captures all-cause mortality occurring between the time of hospital admission and discharge and is typically expressed as a percentage of the total eligible patient population. |
| 30-days mortality | From date of randomization until the end of the study or the date of death from any cause, whichever came first, assessed up to 30 days. | This measure represents the proportion of patients who die from any cause within 30 days of a defined index event. The index event will be high risk of bleeding invasive procedure. The outcome will be expressed as a percentage and will reflect short-term mortality risk beyond the inpatient setting. 30-day mortality is defined as death from any cause occurring within 30 calendar days of the high risk of bleeding invasive procedure regardless of whether the patient is hospitalized, discharged, or transferred at the time of death. Mortality status will be evaluated through telephone follow-up with patients or family members |
Countries
Romania
Contacts
CONTACTIrina Girleanu, Associated Professor
PRINCIPAL_INVESTIGATORIrina Girleanu, Associated Professor
Grigore T. Popa University of Medicine and Pharmacy
Outcome results
None listed