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The study is aimed at evaluating the efficacy and safety of anticoagulant therapy with nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).
Portal vein thrombosis (PVT) is a frequent complication of liver cirrhosis, referred to partial or complete thrombosis formed in the lumen of portal vein or/and branches of it. Currently, clinical guidelines of PVT in cirrhotic patients has not been addressed, and anticoagulant therapy of PVT patients with cirrhosis remains controversial. Although numerable studies have reported that anticoagulation therapy is effective, while a majority of them were respective and a few took control into consideration. In addition, no agreement has reached about the safety of anticoagulation. So, the efficacy and safety of anticoagulant therapy needs more prospective randomized controlled trial to be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nadroparin calcium-warfarin sequential therapy group | Experimental | nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months |
|
| Control group | No Intervention | No anticoagulation therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nadroparin calcium, warfarin | Drug | Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) 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 |
|---|---|---|
| Recanalization Rate | For each venous segment, the vein and residual patent lumen were outlined at the level of the maximum thrombosis. Total lumen area and patent lumen area were calculated with commercially available software. The degree of thrombus occlusion was estimated as a percentage by thrombosis area/total lumen area×100%. The primary outcome was the overall recanalization rate, both complete and partial. Complete recanalization was referred to the complete disappearance of the thrombus in the portal vein trunk, at least one of the two intrahepatic portal vein branches, SMV and SV. Partial recanalization was defined as a more than 50% reduction of the thrombus, with the thrombus not extending to other veins. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Bleeding | Risk of bleeding episodes | 6 months |
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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 | Title | Description |
|---|---|---|
| FG000 | Nadroparin Calcium-warfarin Sequential (NWS) Therapy Group | Nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months Nadroparin calcium, warfarin: Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3. |
| FG001 | Control Group | No anticoagulation therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nadroparin Calcium-warfarin Sequential (NWS) Therapy Group | Nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months. Nadroparin calciumsubcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The minimum and maximum age of the participants was 18 and 75, respectively. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recanalization Rate | For each venous segment, the vein and residual patent lumen were outlined at the level of the maximum thrombosis. Total lumen area and patent lumen area were calculated with commercially available software. The degree of thrombus occlusion was estimated as a percentage by thrombosis area/total lumen area×100%. The primary outcome was the overall recanalization rate, both complete and partial. Complete recanalization was referred to the complete disappearance of the thrombus in the portal vein trunk, at least one of the two intrahepatic portal vein branches, SMV and SV. Partial recanalization was defined as a more than 50% reduction of the thrombus, with the thrombus not extending to other veins. | Posted | Count of Participants | Participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nadroparin Calcium-warfarin Sequential (NWS) Therapy Group | Nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months Nadroparin calcium, warfarin: Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding events | Gastrointestinal disorders | Non-systematic Assessment | Bleeding events consisted of hematemesis, melena, epistaxis, injection-site hemorrhage, and other bleeding events. One patient in the NWS therapy group experienced hematemesis during warfarin administration and discontinued the therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Gao Yanjing | Qilu Hospital of Shandong University | 18560086087 | gaoyanjing@sdu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 3, 2020 | Sep 15, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2020 | Sep 15, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017762 | Nadroparin |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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|
|
| BG001 | Control Group | No anticoagulation therapy. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Etiology | Count of Participants | Participants |
|
| Child-Pugh score | The Child-Pugh score was an quantitative assessment of the liver function reserves. The five indexes including general situation, ascites, the concentration of serum bilirubin, serum albumin and prothrombin time were evaluated to calculate a score. The minimum and maximum Child-Pugh score was 5 and 15, respectively. The lower score indicated a better outcome. | Mean | Standard Deviation | units on a scale |
|
| Model for end-stage liver disease (MELD) score | The minimum and maximum MELD score was 0 and 18, respectively. A lower value was considered to be a better outcome. | Mean | Standard Deviation | units on a scale |
|
| Total bilirubin (μmol/L) | The Total bilirubin referred to the total bilirubine, including direct bilirubine and indirect bilirubine. The minimum and maximum value of Total bilirubin was 5 and 21umol/L, respectively. | Mean | Standard Deviation | μmol/L |
|
| Creatinine (μmol/L) | The minimum and maximum value of Creatinine was 62 and 115μmol/L, respectively. | Mean | Standard Deviation | μmol/L |
|
| International normalized ratio (INR) | The minimum and maximum value of INR was 0.8 and 1.2, respectively. | Mean | Standard Deviation | ratio |
|
| Platelet (*10^9 cells/L) | The minimum and maximum value of Platelet was 125 and 350*10^9 cells/L, respectively. | Mean | Standard Deviation | *10^9 cells/L |
|
| D-dimer(μg/mL) | The maximum value of D-dimer was 0.5μg/mL. | Mean | Standard Deviation | μg/mL |
|
| Albumin (g/L) | The minimum and maximum value of Albumin was 40 and 55g/L, respectively. | Mean | Standard Deviation | g/L |
|
| Low-density lipoprotein cholesterol(LDL-C,mmol/L) | The minimum and maximum value of Low-density lipoprotein cholesterol was 1.00 and 3.37mmol/L, respectively. | Mean | Standard Deviation | mmol/L |
|
| Triglyceride (mmol/L) | The minimum and maximum value of Triglyceride was 0.3 and 1.7mmol/L, respectively. | Mean | Standard Deviation | mmol/L |
|
| Cholesterol (mmol/L) | The minimum and maximum value of Cholesterol was 2.8 and 6.0mmol/L, respectively. | Mean | Standard Deviation | mmol/L |
|
| Esophageal varices | Count of Participants | Participants |
|
| Ascites | Count of Participants | Participants |
|
| Endoscopic treatment | Count of Participants | Participants |
|
| Splenectomy/Partial splenic embolization(PSE) | Count of Participants | Participants |
|
| Extent of portal vein thrombosis(PVT) | Count of Participants | Participants |
|
| OG001 | Control Group | No anticoagulation therapy. |
|
|
| Secondary | Rate of Bleeding | Risk of bleeding episodes | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 1 |
| 32 |
| EG001 | Control Group | No anticoagulation therapy. | 0 | 32 | 0 | 32 | 0 | 32 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |
| 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 |
| Alcoholic |
|
| Cryptogenic |
|
| Splenic vein(SV) only |
|
| MPV + SMV |
|
| MPV + SV |
|
| MPV + SMV + SV |
|