NCT02813538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

2.7 years

First QC Date

June 22, 2016

Last Update Submit

May 21, 2020

Conditions

Hepatic InsufficiencyBlood Coagulation Disorders

Keywords

ThrombelastographyAntithrombin proteinsLiver surgeryLiver function tests

Outcome Measures

Primary Outcomes (2)

  • Establish a relationship between ICG and MCF

    We aim to find a potential association between ICG and MCF measured by thromboelastometry in the first week after surgery

    1 week

  • Establish a relationship between pro and anticoagulant proteins levels and endothelial markers

    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

    1 week

Secondary Outcomes (2)

  • Study blood coagulation disorders after major liver surgery resection

    2 years

  • Study liver function after major liver surgery

    2 years

Study Arms (1)

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 clearanceOther: Thromboelastometry

Interventions

Indocyanine green clearanceDRUG

To evaluate liver function by injection of indocyanine green by a peripheral vein and measure its clearance

Also known as: Verdye
IGC and thromboelastometry
ThromboelastometryOTHER

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

IGC and thromboelastometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gregorio Marañon Hospital

Madrid, 28007, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for anticoagulant proteins levels analysis and thromboelastometry

MeSH Terms

Conditions

Hepatic InsufficiencyBlood Coagulation Disorders

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Luis Olmedilla, PhD

    Gregorio Marañon Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 27, 2016

Study Start

February 5, 2016

Primary Completion

October 1, 2018

Study Completion

April 1, 2019

Last Updated

May 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

Publishing results

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
From december 2018
Access Criteria
For other researchers and editors

Locations

ES(1)