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| Name | Class |
|---|---|
| Shandong Provincial Hospital | OTHER_GOV |
| Taian City Central Hospital | OTHER |
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This study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.
Acute esophagogastric varices bleeding is a common gastroenterological emergency. And the bleeding from ruptured gastric varices is massive and difficulty to stop, even after aggressive pharmacological and conservative treatment. Even after aggressive pharmacological and conservative treatment, maintaining patients without bleeding for a long time is still a challenging clinical problem. Endoscopic tissue adhesive injection is recommended by many international guidelines for acute hemostasis and secondary prevention of gastric variceal bleeding. However, postoperative glue extrusion is inevitable, and the the rebleeding caused by glue ulcers is a problem that is often faced in clinical work. In patients with portal vein thrombosis, the need for anticoagulation and the choice of anticoagulant drugs need to be carefully evaluated in terms of risk and benefit, as the dual conflicts of thrombosis and anticoagulation are involved. At present, there is no in-depth study or consensus on the effect of anticoagulation on rebleeding after glue injection in patients with portal vein thrombosis. This study is of great significance for the treatment and prognosis of patients with gastric varices combined with portal vein thrombosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anticoagulation group | 1 mg/kg of nadroparin calcium or enoxaparin every 12 h, 5000 IU of low molecular weight heparin (LMWH) every 12 h, 20 mg of rivaroxaban once daily, or warfarin adjusted by an increase or decrease of 0.75 mg until the target international normalized ratio (INR) of 2-3 was reached. |
| |
| Control group | No anticoagulation group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low molecular weight heparin | Drug | Anticoagulants were given. When using warfarin, 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 |
|---|---|---|
| the incidence of a bleeding episode from glue cast extrusion | hematemesis, melena, or a ≥ 2 g drop in hemoglobin, with endoscopy-confirmed active spurting or oozing from the site of extrusion of glue casts, or an ulcer with an adherent clot or a visible vessel and no other sources of bleeding | 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| death | death from all causes of illness related to liver dysfunction | 6-month |
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Inclusion Criteria:
Exclusion Criteria:
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All cirrhotic patients complicated with imaging-confirmed PVT and undergoing injection of tissue adhesive for GVs from three tertiary referral hospitals (Qilu Hospital of Shandong University, Shandong Provincial Hospital, and Taian City Central Hospital) were screened.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanjing Gao, PhD. | Contact | 18560086087 | gaoyanjing@sdu.edu.cn | |
| Yunqing Zeng, PhD. | Contact | 18863666093 | z18863666093@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanjing Gao, PhD. | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology,Qilu Hospital,Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D000267 | Tissue Adhesions |
| D004932 | Esophageal and Gastric Varices |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D017762 | Nadroparin |
| D014859 | Warfarin |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| D006425 |
| Hemic and Lymphatic Diseases |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |
| D015110 |
| 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |