Blood Coagulation Profile After Liver Resection.

Completed

• Conditions: Coagulation Disorder

• Registration Number: NCT05824013
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-11
• Study Start: 2023-04-12
• Study First Posted: 2023-04-21
• Primary Completion: 2023-07-31
• Study Completion: 2023-10-31
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood coagulation profile	12 hours	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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy