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OpenTrials
Completed

NCT Number: NCT05824013

Blood Coagulation Profile After Liver Resection.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thromboelastography (TEG®6s)

Diagnostic Test

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 α (K angle), maximum amplitude (MA), and amplitude at 30 minutes (LY30)

Primary outcomes

  1. blood coagulation profile

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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