Trial Outcomes & Findings for Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis (NCT NCT04173429)
NCT ID: NCT04173429
Last Updated: 2021-03-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
6 months
Results posted on
2021-03-02
Participant Flow
Participant milestones
| Measure |
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.
|
Control Group
No anticoagulation therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
Completed the Nadroparin Calcium Therapy and Received Warfarin
|
32
|
0
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nadroparin Calcium-warfarin Sequential (NWS) Therapy Group
n=32 Participants
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.
|
Control Group
n=32 Participants
No anticoagulation therapy.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 year
STANDARD_DEVIATION 9 • n=32 Participants
|
53 year
STANDARD_DEVIATION 10 • n=32 Participants
|
54 year
STANDARD_DEVIATION 9 • n=64 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=32 Participants
|
11 Participants
n=32 Participants
|
22 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=32 Participants
|
21 Participants
n=32 Participants
|
42 Participants
n=64 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Etiology
Hepatitis B virus (HBV)
|
23 Participants
n=32 Participants
|
23 Participants
n=32 Participants
|
46 Participants
n=64 Participants
|
|
Etiology
Hepatitis C virus (HCV)
|
0 Participants
n=32 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=64 Participants
|
|
Etiology
Alcoholic
|
5 Participants
n=32 Participants
|
3 Participants
n=32 Participants
|
8 Participants
n=64 Participants
|
|
Etiology
Cryptogenic
|
4 Participants
n=32 Participants
|
5 Participants
n=32 Participants
|
9 Participants
n=64 Participants
|
|
Child-Pugh score
|
6.51 units on a scale
STANDARD_DEVIATION 1.27 • n=32 Participants
|
6.81 units on a scale
STANDARD_DEVIATION 1.44 • n=32 Participants
|
6.59 units on a scale
STANDARD_DEVIATION 1.35 • n=64 Participants
|
|
Model for end-stage liver disease (MELD) score
|
9.13 units on a scale
STANDARD_DEVIATION 3.39 • n=32 Participants
|
10.00 units on a scale
STANDARD_DEVIATION 3.65 • n=32 Participants
|
9.51 units on a scale
STANDARD_DEVIATION 3.50 • n=64 Participants
|
|
Total bilirubin (μmol/L)
|
18.64 μmol/L
STANDARD_DEVIATION 9.76 • n=32 Participants
|
22.31 μmol/L
STANDARD_DEVIATION 17.00 • n=32 Participants
|
20.3 μmol/L
STANDARD_DEVIATION 13.6 • n=64 Participants
|
|
Creatinine (μmol/L)
|
60.90 μmol/L
STANDARD_DEVIATION 16.00 • n=32 Participants
|
65.78 μmol/L
STANDARD_DEVIATION 16.07 • n=32 Participants
|
63.2 μmol/L
STANDARD_DEVIATION 16.1 • n=64 Participants
|
|
International normalized ratio (INR)
|
1.34 ratio
STANDARD_DEVIATION 0.23 • n=32 Participants
|
1.36 ratio
STANDARD_DEVIATION 0.20 • n=32 Participants
|
1.35 ratio
STANDARD_DEVIATION 0.21 • n=64 Participants
|
|
Platelet (*10^9 cells/L)
|
126.22 *10^9 cells/L
STANDARD_DEVIATION 170.86 • n=32 Participants
|
134.63 *10^9 cells/L
STANDARD_DEVIATION 137.48 • n=32 Participants
|
130 *10^9 cells/L
STANDARD_DEVIATION 150 • n=64 Participants
|
|
D-dimer(μg/mL)
|
1.14 μg/mL
STANDARD_DEVIATION 1.05 • n=32 Participants
|
1.50 μg/mL
STANDARD_DEVIATION 1.32 • n=32 Participants
|
1.31 μg/mL
STANDARD_DEVIATION 1.19 • n=64 Participants
|
|
Albumin (g/L)
|
36.14 g/L
STANDARD_DEVIATION 5.25 • n=32 Participants
|
35.03 g/L
STANDARD_DEVIATION 4.45 • n=32 Participants
|
35.64 g/L
STANDARD_DEVIATION 4.89 • n=64 Participants
|
|
Low-density lipoprotein cholesterol(LDL-C,mmol/L)
|
1.91 mmol/L
STANDARD_DEVIATION 0.69 • n=32 Participants
|
1.77 mmol/L
STANDARD_DEVIATION 0.68 • n=32 Participants
|
1.85 mmol/L
STANDARD_DEVIATION 0.68 • n=64 Participants
|
|
Triglyceride (mmol/L)
|
0.95 mmol/L
STANDARD_DEVIATION 0.51 • n=32 Participants
|
0.83 mmol/L
STANDARD_DEVIATION 0.36 • n=32 Participants
|
0.89 mmol/L
STANDARD_DEVIATION 0.44 • n=64 Participants
|
|
Cholesterol (mmol/L)
|
3.47 mmol/L
STANDARD_DEVIATION 1.02 • n=32 Participants
|
3.50 mmol/L
STANDARD_DEVIATION 1.10 • n=32 Participants
|
3.48 mmol/L
STANDARD_DEVIATION 1.05 • n=64 Participants
|
|
Esophageal varices
Yes
|
26 Participants
n=32 Participants
|
27 Participants
n=32 Participants
|
53 Participants
n=64 Participants
|
|
Esophageal varices
No
|
6 Participants
n=32 Participants
|
5 Participants
n=32 Participants
|
11 Participants
n=64 Participants
|
|
Ascites
Yes
|
17 Participants
n=32 Participants
|
20 Participants
n=32 Participants
|
37 Participants
n=64 Participants
|
|
Ascites
No
|
15 Participants
n=32 Participants
|
12 Participants
n=32 Participants
|
27 Participants
n=64 Participants
|
|
Endoscopic treatment
Yes
|
13 Participants
n=32 Participants
|
9 Participants
n=32 Participants
|
22 Participants
n=64 Participants
|
|
Endoscopic treatment
No
|
19 Participants
n=32 Participants
|
23 Participants
n=32 Participants
|
42 Participants
n=64 Participants
|
|
Splenectomy/Partial splenic embolization(PSE)
Yes
|
9 Participants
n=32 Participants
|
13 Participants
n=32 Participants
|
22 Participants
n=64 Participants
|
|
Splenectomy/Partial splenic embolization(PSE)
No
|
23 Participants
n=32 Participants
|
19 Participants
n=32 Participants
|
42 Participants
n=64 Participants
|
|
Extent of portal vein thrombosis(PVT)
Main portal vein(MPV) only
|
12 Participants
n=32 Participants
|
14 Participants
n=32 Participants
|
26 Participants
n=64 Participants
|
|
Extent of portal vein thrombosis(PVT)
Superior mesenteric vein(SMV) only
|
2 Participants
n=32 Participants
|
3 Participants
n=32 Participants
|
5 Participants
n=64 Participants
|
|
Extent of portal vein thrombosis(PVT)
Splenic vein(SV) only
|
0 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=64 Participants
|
|
Extent of portal vein thrombosis(PVT)
MPV + SMV
|
17 Participants
n=32 Participants
|
9 Participants
n=32 Participants
|
26 Participants
n=64 Participants
|
|
Extent of portal vein thrombosis(PVT)
MPV + SV
|
0 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
2 Participants
n=64 Participants
|
|
Extent of portal vein thrombosis(PVT)
MPV + SMV + SV
|
1 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
3 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: 6 monthsFor 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.
Outcome measures
| Measure |
Nadroparin Calcium-warfarin Sequential Therapy Group
n=32 Participants
nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months
Low molecular weight heparin (LMWH), warfarin: Low molecular weight heparin subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months(LMWH-warfarin group). 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.
|
Control Group
n=32 Participants
No anticoagulation therapy.
|
|---|---|---|
|
Recanalization Rate
|
20 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 monthsRisk of bleeding episodes
Outcome measures
| Measure |
Nadroparin Calcium-warfarin Sequential Therapy Group
n=32 Participants
nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months
Low molecular weight heparin (LMWH), warfarin: Low molecular weight heparin subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months(LMWH-warfarin group). 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.
|
Control Group
n=32 Participants
No anticoagulation therapy.
|
|---|---|---|
|
Rate of Bleeding
|
1 Participants
|
0 Participants
|
Adverse Events
Nadroparin Calcium-warfarin Sequential (NWS) Therapy Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nadroparin Calcium-warfarin Sequential (NWS) Therapy Group
n=32 participants at risk
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.
|
Control Group
n=32 participants at risk
No anticoagulation therapy.
|
|---|---|---|
|
Gastrointestinal disorders
Bleeding events
|
3.1%
1/32 • 6 months
|
0.00%
0/32 • 6 months
|
Additional Information
Professor Gao Yanjing
Qilu Hospital of Shandong University
Phone: 18560086087
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place