Completed

NCT Number: NCT04397289

Anticoagulation Therapy After Splenectomy in Cirrhosis Patient

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:

1. ) Portal vein system thrombosis (PVST) found by preoperative color Doppler ultrasound or MRI examination; 2. ) Liver cirrhosis complicated with liver tumor; 3. ) Liver cirrhosis complicated with blood system diseases; 4. ) 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.

1. ) Heparin group 2. ) Rivaroxaban group 3. ) Control group.

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Key information

Conditions

Liver Cirrhosis Anticoagulant-induced Bleeding Cardiovascular Diseases Digestive System Diseases Embolism and Thrombosis Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension Thrombosis Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

the first hospital of xi'an jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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.

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heparin and Rivaroxaban

Drug

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

Other names: platelet collection

Primary outcomes

thrombosis formation

Time frame: 1 year after surgery.

The evaluation index is the incidence of PVST

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

The Preventive Effect of Anticoagulants on the Formation of Thrombosis After Splenectomy in Liver Cirrhosis Patients With Portal Hypertension

Acronym: ATASICP

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: May 21, 2020
Registry last updated: Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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