Blood Coagulation Profile After Liver Resection.

Coagulation Disorder Clinical Trial

Official title:

Blood Caogulation Profile After Liver Resection. Comparison of Conventional Blood Coagulation Tests With Thromboelastography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824013
• Other study ID #: 5492
• Status: Completed
• Start date: April 12, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: April 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders

Intervention

Diagnostic Test:
• thromboelastography (TEG®6s)
blood samples for conventional coagulation test were obtained in vacutainer tubes from an arterial line. Two blood citrate samples (3 ml, sodium citrate solution, Vacuette® Blood Tubes) were also collected for the laboratory conventional coagulation tests (aPTT, INR, D-dimer levels, Antithrombin III) and TEG®6s assessment. The TEG parameters include reaction time (R), clot formation time (K), angle or a (K angle), maximum amplitude (MA), and amplitude at 30 minutes (LY30)

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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 re — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood coagulation profile	Evaluate whether to use TEG®6s, in addition to coagulation tests conventional, optimizes the postoperative hemocoagulation management of patients undergoing resective liver surgery in terms of consumption transfusion of plasma and blood products.	12 hours