NCT02398357

Brief Summary

To determine the effect and safety of anticoagulation after endoscopic therapy in cirrhotic patients with portal vein thrombosis and to explore whether it can decrease the short-term rebleeding rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

2.4 years

First QC Date

March 19, 2015

Last Update Submit

December 8, 2015

Conditions

Portal Vein ThrombosisLiver Cirrhosis

Keywords

anticoagulationZelen-designed randomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Recanalization rate of PVT

    Patients will receive Doppler ultrasound before enrolled and after followed up for 8 weeks

    8 weeks

Secondary Outcomes (2)

  • Rebleeding rate

    8 weeks

  • Incidence rate of complications

    8 weeks

Study Arms (2)

Control

NO INTERVENTION

No anticoagulation，just routine follow-up

Anticoagulation

EXPERIMENTAL

Nadroparin Calcium and Warfarin

Drug: Nadroparin Calcium and Warfarin

Interventions

Nadroparin Calcium and WarfarinDRUG

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,alone with Nadroparin Calcium 4100IU／d，subcutaneous, when taking endoscopy therapy .

Anticoagulation

Eligibility Criteria

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

You may qualify if:

  • Age between 18-70 years old;
  • A clinical, radiological or histologic diagnosis of Liver cirrhosis and portal hypertension;
  • Diagnosed of Portal vein thrombosis;
  • Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
  • Have undergone endoscopy to prevent variceal rebleeding.

You may not qualify if:

  • Age \<18 or \>70 years;
  • Portal vein thrombosis diagnosed before 6 months;
  • Patients with signs of acute PVT such as fever，abdominal pain or intestinal obstruction，who should be treated immediately;
  • Pregnant or nursing;
  • Hepatocellular carcinoma;
  • Severe cardiopulmonary diseases or concomitant renal insufficiency;
  • cavernous transformation of the portal vein;
  • Contradictions to endoscopy;
  • Contradictions to anticoagulation,such as:allergy to LMWH or warfarin, severe uncontrolled hypertension, history of hemorrhagic cerebral vascular accident, recent peptic ulcer disease, bacterial endocarditis, ulcerative colitis，sustained platelet count \< 50 x103/uL);
  • Taking immunosuppressive agent;
  • Coagulation disorders other than the liver disease related;
  • Variceal bleeding failed to control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

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

  • Shiyao Chen, Professor

    Shanghai Zhongshan Hospital

    STUDY DIRECTOR

Central Study Contacts

Shiyao Chen, Professor

CONTACT

86-13601767310chen.shiyao@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of Gastroenterology

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 25, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

CN(1)