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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04976543
Other study ID # 20200202-Qilu
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 1, 2020
Est. completion date June 28, 2022

Study information

Verified date February 2020
Source Qilu Hospital of Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin sequential (NWS) anticoagulation therapy after endoscopic therapy in PVT patients with cirrhosis and AVB.


Description:

Acute variceal bleeding is one of the most serious complications of liver cirrhosis and is associated with significant morbidity and mortality. Portal vein thrombosis (PVT) aggravates portal hypertension and worsens hemorrhage, which Increases the risk of endoscopic therapy, and PVT has been shown to be associated with a longer time to variceal eradication, a higher risk of variceal relapse and rebleeding. So, PVT should be treated earlier. Data regarding the safety and initiation time of anticoagulant therapy in PVT patients with variceal bleeding after endoscopic therapy is lacking. Aim of this study is to verify the efficacy and safety of NWS anticoagulation therapy in PVT patients with cirrhosis and AVB after endoscopic therapy and further to explored the appropriate initiation time of NWS anticoagulation therapy after EVL in these patients.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date June 28, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - clinical diagnosis of cirrhosis - Portal hypertension with esophageal and gastric varices - diagnosis of PVT by imaging examination - undergo endoscopic therapy Exclusion Criteria: - older than 75 years - uncontrolled active bleeding - hepatocellular carcinoma or other extrahepatic malignancy - on-going or received antithrombotic/thrombolytic treatment - previous treatment with TIPSS - cavernous transformation of the portal vein - platelet count lower than 10*10 ^ 9/L, creatinine more than 170 µmol/L - Budd-Chiari syndrome - pregnancy or breast-feeding period - severe cardiopulmonary diseases, severe systemic infection or sepsis - inability to sign informed consent

Study Design


Intervention

Drug:
nadroparin calcium-warfarin sequential anticoagulation
The NWS therapy group were given a subcutaneous injection of nadroparin calcium every 12 hours for 1 month and switched to warfarin for 5 months. Warfarin was initiated at least 5 days before nadroparin calcium was stopped. International normalized ratio (INR) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.

Locations

Country Name City State
China Department of Gastroenterology,Qilu Hospital,Shandong University Jinan Shandong

Sponsors (3)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University Liaocheng People's Hospital, Taian City Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary rate of overall recanalization the sum of the fraction of patients who had complete or partial recanalization 6-month
Primary rate of bleeding rates of upper gastrointestinal (GI) rebleeding, epistaxis, injection-site hemorrhage, and other bleeding events 6-month
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