Clinical trial NCT05824013: Blood Coagulation Profile After Liver Resection.
Official title: Blood Caogulation Profile After Liver Resection. Comparison of Conventional Blood Coagulation Tests With Thromboelastography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing liver surgery resective for primary or secondary neoplastic disease admitted to surgical intensive care unit at the end of surgery

Brief summary: Liver resection is the treatment of choice in patients with primary or metastatic liver neoplasms, benign liver neoplasms and numerous biliary diseases. In these patients, in the postoperative period,several factors can induce a transient alteration of the synthesis hepatic coagulation factors such as size of the lesion liver, underlying liver disease (e.g. malignancy), pre-existing cirrhosis, duration of both surgery and vascular clamping, and blood loss. So far, some studies have shown that conventional coagulation tests indicate a hypocoagulable state which may lead to excessive transfusions of blood products or an increased risk of thromboembolic events related to delayed initiation of thromboprophylaxis in the postoperative period. In an attempt to optimizing the state of coagulation, recently there is increased interest for viscoelastic coagulation testing (thromboelastography and rotational thromboelastometry). The results of these studies have shown that these patients often have a hypercoagulable and non hypocoagulable profile as evidenced by conventional coagulation tests.

the purpose of the study is to evaluate whether the combination of coagulation tests conventional systems and new thromboelastography can increase the quality of surveillance of the coagulation state after liver surgery, in order to optimize the management of postoperative blood coagulation of these patients.


Eligibility criteria: Inclusion Criteria:

* Elective liver resection surgery for liver cancer primary or metastatic
* Admission to surgical intensive care unit at the end of the surgery.

Exclusion Criteria:

* Renal disease (creatinine clearance \< 30 ml/min)
* pregnancy
* Benign liver disease
* Emergency surgery
* Reintervention

Primary outcomes:
measure: blood coagulation profile
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
References:
citation: Ardito F, Vellone M, Barbaro B, Grande G, Clemente G, Giovannini I, Federico B, Bonomo L, Nuzzo G, Giuliante F. Right and extended-right hepatectomies for unilobar colorectal metastases: impact of portal vein embolization on long-term outcome and liver recurrence. Surgery. 2013 Jun;153(6):801-10. doi: 10.1016/j.surg.2013.02.001.
citation: Dumitrescu G, Januszkiewicz A, Agren A, Magnusson M, Isaksson B, Wernerman J. The temporal pattern of postoperative coagulation status in patients undergoing major liver surgery. Thromb Res. 2015 Aug;136(2):402-7. doi: 10.1016/j.thromres.2015.05.023. Epub 2015 May 24.
citation: Blasi A, Molina V, Sanchez-Cabus S, Balust J, Garcia-Valdecasas JC, Taura P. Prediction of thromboembolic complications after liver resection for cholangiocarcinoma: is there a place for thromboelastometry? Blood Coagul Fibrinolysis. 2018 Jan;29(1):61-66. doi: 10.1097/MBC.0000000000000672.