Anticoagulation Therapy After Splenectomy in Cirrhosis Patient (ATASICP)
Primary Purpose
Liver Cirrhosis, Portal Hypertension, Anticoagulant-induced Bleeding
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Heparin and Rivaroxaban
Sponsored by
About this trial
This is an interventional prevention trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension
Exclusion Criteria:
- Portal vein thrombosis found by preoperative color Doppler ultrasound or MRI examination;
- Liver cirrhosis complicated with liver tumor;
- Liver cirrhosis complicated with blood system diseases;
- Patients who have not signed the informed consent form.
Sites / Locations
- the first hospital of xi'an jiaotong University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Heparin group
Rivaroxaban group
Control group
Arm Description
Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation. Warfarin 1.25-2.5 mg po qd, 30 days after operation. PT/INR was kept at 1.25-1.5.
Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.
No preventive intervention measures.
Outcomes
Primary Outcome Measures
thrombosis formation
The evaluation index is the incidence of PVST
Secondary Outcome Measures
Full Information
NCT ID
NCT04397289
First Posted
November 6, 2019
Last Updated
August 25, 2021
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT04397289
Brief Title
Anticoagulation Therapy After Splenectomy in Cirrhosis Patient
Acronym
ATASICP
Official Title
The Preventive Effect of Anticoagulants on the Formation of Thrombosis After Splenectomy in Liver Cirrhosis Patients With Portal Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
1. Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension.
Exclusion criteria:
) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;
) Liver cirrhosis complicated with liver tumor;
) Liver cirrhosis complicated with blood system diseases;
) Patients who have not signed the informed consent form.
2. Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.
) Heparin group
) Rivaroxaban group
) Control group.
Detailed Description
1. Inclusion and Exclusion Criteria Inclusion criteria: Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension.
Exclusion criteria:
) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination;
) Liver cirrhosis complicated with liver tumor;
) Liver cirrhosis complicated with blood system diseases;
) Patients who have not signed the informed consent form.
2. Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.
) Heparin group: Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation. Warfarin 1.25-2.5 mg po qd, 30 days after operation. PT(prothrombin time)/INR(international normalized ratio) was kept at 1.25-1.5.
) Rivaroxaban group: Rivaroxaban 10mg po qd from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.
) Control group: No preventive intervention measures. If platelets in the above groups are > 500× 109/L, aspirin 100 mg qd is added for 1 month. If platelets are > 1000× 109/L, platelet collection is performed.
3. Monitoring indicators Color Doppler ultrasound was reexamined 1, 2, 3 and 4 weeks after operation to find out whether PVST was present. Abdominal CT was performed when PVST was suspected. After the patient's condition is stable, the portal vein system ultrasound is reviewed monthly, and the follow-up time is 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Portal Hypertension, Anticoagulant-induced Bleeding, Thrombosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heparin group
Arm Type
Experimental
Arm Description
Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation. Warfarin 1.25-2.5 mg po qd, 30 days after operation. PT/INR was kept at 1.25-1.5.
Arm Title
Rivaroxaban group
Arm Type
Experimental
Arm Description
Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
No preventive intervention measures.
Intervention Type
Drug
Intervention Name(s)
Heparin and Rivaroxaban
Other Intervention Name(s)
platelet collection
Intervention Description
Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation
Primary Outcome Measure Information:
Title
thrombosis formation
Description
The evaluation index is the incidence of PVST
Time Frame
1 year after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inpatients who received laparotomy or laparoscopic splenectomy according to clinical, B-ultrasound scan, CT or MRI diagnosis of cirrhosis and portal hypertension
Exclusion Criteria:
Portal vein thrombosis found by preoperative color Doppler ultrasound or MRI examination;
Liver cirrhosis complicated with liver tumor;
Liver cirrhosis complicated with blood system diseases;
Patients who have not signed the informed consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yingmin yao, PhD
Organizational Affiliation
the first hospital of xi'an jiaotong university
Official's Role
Study Director
Facility Information:
Facility Name
the first hospital of xi'an jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Anticoagulation Therapy After Splenectomy in Cirrhosis Patient
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