Rotational Thromboelastometry (ROTEM)-guided blood product in patients with cirrhosis undergoing invasive

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: Use of Rotational Thromboelastometry to guide blood product (fresh frozen plasma (FFP) and platelet) transfusion prior to invasive procedures. ROTEM analysis will be conducted and blood components if needed, will be given prior to the procedure. ROTEM cut offs will be based on trauma guidelines: Platelets will only be given if EXTEM MCF less than 45mm with FIBTEM MCF greater than or equal to 18mm irrespective of platelet count. FFP will only be given if EXTEM CT > 80 seconds or INTEM CT >240 seconds irrespective of INR/PT/APTT CONDITION: Blood ‐ Clotting disorders Liver cirrhosis;Coagulopathy; ; Liver cirrhosis ; Coagulopathy Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon Surgery ‐ Other surgery PRIMARY OUTCOME: Amount of pre‐procedural blood product (FFP/platelets) given [Day 0 (prior to procedure); (assessed through electronic medical records)] Peri‐procedural bleeding complications (e.g. immediate, and delayed bleeding); (assessed through electronic medical records and patient survey)[day 7] Proportion of procedures requiring prophylactic transfusion; (assessed through electronic blood product ordering and delivery records); ; [Prior to procedure (day 0)] SECONDARY OUTCOME: Hospital length of stay[Day 0, 7, 28 ; (assessed through patient survey and electronic hospital records)] Procedure‐related complications other than bleeding (e.g. thrombosis, infection) ; (assessed through patient survey and electronic hospital records)[Day 0, 7 and 28] Survival [28 day ; (assessed through electronic hospital records and patient reports)] Transfusion‐related side effects (e.g. volume overload, transfusion reactions, transfusion‐related lung injury) ; (assessed through patient survey and electronic hospital records)[Day 0 ] INCLUSION CRITERIA: ‐Males and females aged 18 years or older ‐Cirrhosis ‐Planned for an invasive procedure ‐Coagulopathic on the basis of conventional coagulation tests ‐Able to give informed consent
Epistemonikos ID: 43facc70ba801ed1e563b3016afd381590a1a561
First added on: Aug 24, 2024