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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thromboelastography (TEG) | Experimental | Patients in the TEG group received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, only if INR was higher than 1.8 and r time longer than 40 minutes. They received platelets at the amount of 1 apheresis Unit, only if platelets count was lower than 50000/μl and MA was shorter than 30 millimeter. |
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| Standard of Care (SOC) | Active Comparator | In the SOC group patients received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, when INR was higher than 1.8. They received platelets at the amount of 1 apheresis Unit, when platelets count was lower than 50000/μl. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thromboelastography to guide blood products infusion | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison in the amount of blood products transfused between the groups | Comparison of the number of patients receiving blood products (FFPor PLTs or both), and the amount of blood products between the study groups | 48 hours from admission |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedure bleeding | Comparison of the number of patients having bleeding episodes after procedure between the study groups | 48 hours from admission |
| Survival | Comparison of patients survival between the study groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lesley De pietri, MD | Azienda Ospedaliero-Universitaria di Modena-Policlinico, Division of Anaesthesiology and Intensive Care Unit | Principal Investigator |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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|
| Standard of care coagulation tests to guide blood products infusion | Procedure | Patients received FFP (10 ml/kg) if INR>1.8 and/or PLTS (10 units/Kg) If PLTs count < 50000/μl |
|
| 90 days patient survival |
| Transfusion related side effects | Comparison of the number of patients presenting transfusion side effects between the study groups | 48 hours from admission |
| Procedure-related complications | Comparison of the number of patients presenting post-procedures complication other than bleeding between the study groups | during hospitalization (mean 4 weeks) |
| Comparison between blood products costs between groups | 48 hours from admission |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |