Blood Coagulation Profile After Liver Resection.

NCT ID: NCT05824013

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-12

Study Completion Date

2023-10-31

Brief Summary

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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

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Conditions

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Coagulation Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 23701876 (View on PubMed)

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.

Reference Type RESULT
PMID: 26048400 (View on PubMed)

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.

Reference Type RESULT
PMID: 29045240 (View on PubMed)

Other Identifiers

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5492

Identifier Type: -

Identifier Source: org_study_id

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