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| Name | Class |
|---|---|
| Liaocheng People's Hospital | OTHER |
| Taian City Central Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NWS group | Experimental | nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months |
|
| control group | No Intervention | no anticoagulation therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nadroparin calcium-warfarin sequential anticoagulation | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of overall recanalization | the sum of the fraction of patients who had complete or partial recanalization | 6-month |
| rate of bleeding | rates of upper gastrointestinal (GI) rebleeding, epistaxis, injection-site hemorrhage, and other bleeding events | 6-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanjing Gao, PhD.MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology,Qilu Hospital,Shandong University | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D004932 | Esophageal and Gastric Varices |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |