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Major Liver Resection: Early Clotting Disorders and Functional Impairment.

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ClinicalTrials.gov Identifier: NCT02813538
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Patricia Duque González, Hospital General Universitario Gregorio Marañon

Brief Summary:
The aim of this study is to evaluate early clotting disorders through thromboelastogram and anticoagulant proteins levels (maybe also endothelial markers) and liver function by indocyanine green clearance after major liver resection and search for a potential relationship between them.

Condition or disease Intervention/treatment
Hepatic Insufficiency Blood Coagulation Disorders Drug: Indocyanine green clearance Other: Thromboelastometry

Detailed Description:
We are prospectively recording data from patients undergoing major liver resection. We obtain a full procoagulant and anticoagulant profile preoperatively and, at first, second and sixth day after surgery. We also measure indocyanine green (ICG) clearance preoperatively and in the first two postoperative days. We are also recording clinical data, focusing on medical and surgical complications. We aim to establish the potential value of ICG clearance and or coagulation profile to predict clinical complications

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Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Hypercoagulability and Liver Function After Major Liver Resection
Actual Study Start Date : February 5, 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
IGC and thromboelastometry
Patients that have hyper, normo o hypcoagulability measured by tromboelastometry and anticoagulant proteins levels early after major liver resection and clinical evolution and patients with liver funcion impairment or without it, measured by indocyanine green clearance early after surgery and clinical evolution
Drug: Indocyanine green clearance
To evaluate liver function by injection of indocyanine green by a peripheral vein and measure its clearance
Other Name: Verdye

Other: Thromboelastometry
To evaluate blood coagulation impairment by obtaining blood sample from a peripheral vein and measure anticoagulant proteins levels plus obtaining thromboelastometry




Primary Outcome Measures :
  1. Establish a relationship between ICG and MCF [ Time Frame: 1 week ]
    We aim to find a potential association between ICG and MCF measured by thromboelastometry in the first week after surgery

  2. Establish a relationship between pro and anticoagulant proteins levels and endothelial markers [ Time Frame: 1 week ]
    We aim to find a potential association between procoagulant factor levels, protein C,S and ATIII with thrombomodulin, heparan sulfate and syndecan-1 in the first week after surgery


Secondary Outcome Measures :
  1. Study blood coagulation disorders after major liver surgery resection [ Time Frame: 2 years ]
    We aim to characterize blood coagulation disorders during the first week after major liver surgery in our sample of patients

  2. Study liver function after major liver surgery [ Time Frame: 2 years ]
    We aim to study the predictive value of indocyanine green clearance for liver impairment after major liver surgery in our sample of patients


Biospecimen Retention:   Samples Without DNA
Blood samples for anticoagulant proteins levels analysis and thromboelastometry


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments
Criteria

Inclusion Criteria:

  • Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments

Exclusion Criteria:

  • Indocyanin green allergy
  • Thyrotoxicosis
  • Thrombophilia
  • Lupus anticoagulant
  • Coagulation factor deficiency
  • Venous thromboembolism in the last 3 years
  • Pulmonary thromboembolism in the last 3 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813538


Locations
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Spain
Gregorio Marañon Hospital
Madrid, Spain, 28007
Sponsors and Collaborators
Hospital General Universitario Gregorio Marañon
Investigators
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Study Director: Luis Olmedilla, PhD Gregorio Marañon Hospital
Additional Information:

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Responsible Party: Patricia Duque González, MD, PhD, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT02813538    
Other Study ID Numbers: HGUGregorioMaranonCRH2AT
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publishing results
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: From december 2018
Access Criteria: For other researchers and editors
Keywords provided by Patricia Duque González, Hospital General Universitario Gregorio Marañon:
Thrombelastography
Antithrombin proteins
Liver surgery
Liver function tests
Additional relevant MeSH terms:
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Hepatic Insufficiency
Liver Failure
Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Liver Diseases
Digestive System Diseases