Hepatic InsufficiencyNCT02813538
Major Liver Resection: Early Clotting Disorders and Functional Impairment.
An observational study of Hepatic Insufficiency and Blood Coagulation Disorders, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Insufficiency, Blood Coagulation Disorders
- What is being tested?
- Indocyanine green clearance and Thromboelastometry
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2016to Apr 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments
Who may be able to join
- Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments
Who cannot join
- Indocyanin green allergy
- Thyrotoxicosis
- Thrombophilia
- Lupus anticoagulant
- Coagulation factor deficiency
- Venous thromboembolism in the last 3 years
- Pulmonary thromboembolism in the last 3 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypercoagulability and Liver Function After Major Liver Resection
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.
Read the 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
- Conditions
- Hepatic Insufficiency, Blood Coagulation Disorders
- Being tested
- Indocyanine green clearance, Thromboelastometry
- Keywords
- Thrombelastography, Antithrombin proteins, Liver surgery, Liver function tests
- Medical subject headings
- Hepatic Insufficiency, Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green clearanceDrug
Also called Verdye
To evaluate liver function by injection of indocyanine green by a peripheral vein and measure its clearance
ThromboelastometryOther
To evaluate blood coagulation impairment by obtaining blood sample from a peripheral vein and measure anticoagulant proteins levels plus obtaining thromboelastometry
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Indocyanine green clearance; Other: Thromboelastometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 week
Secondary outcomes (2)
Study blood coagulation disorders after major liver surgery resection
We aim to characterize blood coagulation disorders during the first week after major liver surgery in our sample of patients
Measured: 2 years
Study liver function after major liver surgery
We aim to study the predictive value of indocyanine green clearance for liver impairment after major liver surgery in our sample of patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start5 Feb 2016
- Primary completionOct 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Duque González, Hospital General Universitario Gregorio Marañon
- Investigators
- Luis Olmedilla, PhD, Study director, Gregorio Marañon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813538
- Sponsor's protocol ID
- HGUGregorioMaranonCRH2AT
- Status last verified
- May 2020
- First submitted
- 22 Jun 2016
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publishing results
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypercoagulability and Liver Function After Major Liver Resection
- ClinicalTrials.gov ID
- NCT02813538
- Acronym / sponsor ID
- HGUGregorioMaranonCRH2AT
- Conditions
- Hepatic Insufficiency, Blood Coagulation Disorders
- Keywords
- Thrombelastography, Antithrombin proteins, Liver surgery, Liver function tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- 5 Feb 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IGC and thromboelastometry | – | Drug: Indocyanine green clearance, Other: ThromboelastometryPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments
Key inclusion criteria (1 listed)
- Patients undergoing major liver surgery defined as resection of 3 or more hepatic segments
Key exclusion criteria (7 listed)
- Indocyanin green allergy
- Thyrotoxicosis
- Thrombophilia
- Lupus anticoagulant
- Coagulation factor deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine green clearanceAlso: VerdyeTo evaluate liver function by injection of indocyanine green by a peripheral vein and measure its clearance | Drug | IGC and thromboelastometry |
| ThromboelastometryTo evaluate blood coagulation impairment by obtaining blood sample from a peripheral vein and measure anticoagulant proteins levels plus obtaining thromboelastometry | Other | IGC and thromboelastometry |
Primary outcome
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
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
2 secondary outcomes
Study blood coagulation disorders after major liver surgery resection
Time frame: 2 years
Study liver function after major liver surgery
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: Yes. Publishing results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Olmedilla, PhD study director
Gregorio Marañon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Insufficiency and Blood Coagulation Disorders, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a relationship between ICG and MCF (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.