Hemostasis in Liver Cirrhosis and Hepatocellular Cancer

NCT ID: NCT06212635

Last Updated: 2024-01-19

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

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-02

Study Completion Date

2028-12-01

Brief Summary

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Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.

Detailed Description

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The rebalanced hemostasis in liver cirrhosis is vulnerable and patients are prone to both bleeding and thrombosis. There are today no gold standard for evaluating the hemostasis and we will evaluate novel methods for this.

Conditions

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Hemostasis in Decompensated Liver Cirrhosis Inflammation in Decompensated Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-acute decompensated liver círrhosis

Refractory ascites, low grade encephalopathy but manages to stay at home and only come in ofr check-ups.

T-TAS

Intervention Type DIAGNOSTIC_TEST

Blood test, laboratory assays

Acute decompensated liver cirrhosis

Acute event causing further decompensation and the need for in-patient care

T-TAS

Intervention Type DIAGNOSTIC_TEST

Blood test, laboratory assays

Acute on chronic liver failure

ACLF 1-3 accordic to criterias established through the Cannonic study.

T-TAS

Intervention Type DIAGNOSTIC_TEST

Blood test, laboratory assays

Controls

Healthy individuals

T-TAS

Intervention Type DIAGNOSTIC_TEST

Blood test, laboratory assays

Interventions

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T-TAS

Blood test, laboratory assays

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Quantra OHP

Eligibility Criteria

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Inclusion Criteria

* Patients with decompensated liver cirrhosis
* 18 years or older.
* Healthy individuals 18 years or older will serve as controls.

Exclusion Criteria

* • Extrahepatic malignancy or recurrence of such within the last year.

* Diagnosis of non-cirrhotic coagulopathy, coagulation disorder or thrombophilia prior to inclusion.
* Diagnosis of hematological disease such as hematologic malignancies, non-cirrhotic thrombocytopenia or thrombocytosis, Polycytemia Vera, hemoglobinopathies
* Previous liver transplantation.
* Transfusions the last 7 days.
* Treatment with platelet inhibitors or anticoagulant except for prophylactic dosage of LMWH. If a prophylactic dose of LMWH has been used study sampling with addition of antiFXa must be taken \>12 hours after the last injection.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Region Stockholm

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Magnusson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Stockholm, Karolinska Institute

Locations

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Karolinska University Hospital

Stockholm, Huddinge, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Sanna Norén, MD, PhDstudent

Role: CONTACT

+46703131799

Maria Magnusson, MD, PhD

Role: CONTACT

Facility Contacts

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Sanna Norén, MD, PhDstudent

Role: primary

Other Identifiers

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2020-00316200610

Identifier Type: -

Identifier Source: org_study_id

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