Clinical trial NCT04976543: Safety of Anticoagulant Therapy After Endoscopic Treatment
Official title: Initiation of NWS Anticoagulation Therapy After Oesophageal Variceal Band Ligation Was Safe in Portal Vein Thrombosis Patients With Cirrhosis and Acute Variceal Bleeding: A Multi-central Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis
Portal Vein Thrombosis
Esophageal and Gastric Varices
Anticoagulant-induced Bleeding
Keywords: endoscopic therapy
endoscopic variceal band ligation
warfarin
nadroparin calcium
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Liaocheng People's Hospital
name: Taian City Central Hospital
First posted: 2021-07-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of overall recanalization
timeFrame: 6-month
measure: rate of bleeding
timeFrame: 6-month
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology,Qilu Hospital,Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanjing Gao, PhD.MD
role: PRINCIPAL_INVESTIGATOR
References: