NCT02526303

Brief Summary

The purpose of this study is to determine the safety and efficacy of anticoagulation in the treatment of non-occlusive portal vein thrombosis in patients with liver cirrhosis.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

First QC Date

August 13, 2015

Last Update Submit

February 13, 2017

Conditions

Liver CirrhosisPortal Vein ThrombosisAnticoagulation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Portal Vein Recanalization as Assessed by Cummulative Rate

    2 year

Secondary Outcomes (8)

  • Number of Participants With Liver Decompensation as Assessed by Cummulative Rate

    2

  • Number of Participants Who Show Improvement in Child-Pugh score > 2 Points

    2 years

  • Number of Participants Who Show Improvement in MELD Score > 5 points

    2 year

  • Number of Participants with Improved Stiffness of liver and Spleen as Assessed by Transient Elastography

    2 years

  • Number of Participants with Recurrence of Thrombotic Events as Assessed by Cummulative Rate

    2 years

  • +3 more secondary outcomes

Study Arms (2)

Anticoagulation

EXPERIMENTAL

Drug: Nadroparin Calcium and Warfarin Patients will take warfarin started at a dose of 2.5mg/d and with titration of dose to maintain a target INR of 2-3,along with Nadroparin Calcium 85IU／kg，subcutaneous, q12h,for the first 5 days at least.

Drug: Nadroparin Calcium and Warfarin

Non-anticoaglated

NO INTERVENTION

No anticoagulatoin or other treatment for PVT will be used in this group of patients.

Interventions

Nadroparin Calcium and WarfarinDRUG

Warfarin (with nadroparin calcium at the first 5 days at least) until recanalization or 1 year

Anticoagulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent was obtained
  • liver cirrhosis
  • Non-occlusive portal vein thrombosis
  • No history of variceal bleeding or receive endoscopy or β-blocker for the prevention of patients with G3 or G2 with red marks within 3 months before enrollment
  • No plan for liver transplantation
  • Age between 18 and 70
  • Child-Pugh score ≤ 11

You may not qualify if:

  • Acute PVT
  • Fibrotic cord of PV
  • Isolated splenic vein thrombosis or isolated superior mesenteric vein thrombosis
  • Extensive superior mesenteric vein thrombosis involving the distal part
  • Known coagulation disorder besides liver cirrhosis
  • HCC or other malignant tumor
  • Patients with G2 varices with red mark or G3 but did not underwent any preventive endoscopy or β-blockers
  • Platelet count \< 10×109/L
  • Receive contraceptive, anticoagulation or antiplatelet drug
  • Receiving thrombolysis treatment
  • Receiving TIPS or shunting surgery
  • Bleeding tendency
  • Recent gastrointestinal bleeding like digestive ulcer or hemorrhagic stroke
  • Severe portal hypertension，for example, refractory ascite or acute variceal bleeidng
  • Spontaneous bacterial peritonitis
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Qi X, Han G, Fan D. Management of portal vein thrombosis in liver cirrhosis. Nat Rev Gastroenterol Hepatol. 2014 Jul;11(7):435-46. doi: 10.1038/nrgastro.2014.36. Epub 2014 Apr 1.

    PMID: 24686266BACKGROUND

  • Nery F, Chevret S, Condat B, de Raucourt E, Boudaoud L, Rautou PE, Plessier A, Roulot D, Chaffaut C, Bourcier V, Trinchet JC, Valla DC; Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire. Causes and consequences of portal vein thrombosis in 1,243 patients with cirrhosis: results of a longitudinal study. Hepatology. 2015 Feb;61(2):660-7. doi: 10.1002/hep.27546. Epub 2015 Jan 5.

    PMID: 25284616BACKGROUND

Related Links

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

NadroparinWarfarin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Guohong Han, PhD,MD

    Xijing Hospital of Digestive Diseases, Fourth Military Medical University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 18, 2015

Primary Completion

February 1, 2017

Last Updated

February 15, 2017

Record last verified: 2017-02