C22 C78.7 K73 K74 K75
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Indication for elective laparoscopic or conventional liver resection (minor and major resections) - ASA I-III
Exclusion criteria
Exclusion criteria: - Preoperative transfusion of thrombocyte concentrates within the last 4 weeks - Basic haematological disease of bone marrow or of thrombocytes (leukemia, lymphoma, MDS, polycytaemia vera, thrombocythemia, thalassemia, etc.) - Known congenital coagulation disorder (protein C/S-deficiency, APC resistance, factor V-Leiden, vWJ syndrome, etc.) - Hypersplenism - Haemodialysis - Cirrhosis of the liver CHILD B or C - Heart failure >NYHA II - Pregnancy - Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoints: - description of the distribution of perioperative changes in platelet function during liver resection - association of perioperative alteration of platelet function with the postoperative platelet count at 1. POD and the perioperative change in platelet count - prognostic value of perioperative changes in platelet function and platelet count in relation to liver regeneration | — |
Secondary
| Measure | Time frame |
|---|---|
| - Platelet count pre- and postoperative - Platelet function and platelet count on POD 1,3,5,7 - Postoperative liver function - Postoperative liver regeneration (clinical and laboratory chemistry) - Postoperative hypertrophy of residual liver at POD 7 (+/-2 days) and 3 months post-op in all patients with a resection extent of at least 2 anatomical segments using volumetry on the basis of a post-operative MRT - Postoperative hypertrophy of the residual liver at POD 7 (+/-2 days) and 3 months post-op using volumetry based on postoperative ultrasound at POD 5 and 3 months post-op - Prevalence of acute as well as chronic postoperative liver failure stratified by subgroups (group A and B) - Postoperative transfusion of blood products - Postoperative ITS stay and intubation duration - Postoperative morbidity (especially ascites and bile leaks; within the hospital stay and 3 months postoperatively) - Postoperative mortality (within the length of hospital stay and 3 months postoperatively) - Re-operation rate - Intervention rate (bleeding, bile leakage, behaviour) - Histology of the liver parenchyma with scoring for fibrosis/cirrhosis, CASH, steatosis - MR-morphological structural postoperative changes of the liver parenchyma | — |
Countries
Germany
Contacts
Universitätsklinikum Carl-Gustav-Carus Dresden an der TU DresdenKlinik und Poliklinik für Viszeral-, Thorax- und Gefäßchirurgie