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Anticoagulation Therapy After Splenectomy in Cirrhosis Patient (ATASICP)

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Xi'an Jiaotong University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Portal Hypertension
Thrombosis
Liver Cirrhosis
Anticoagulant-induced Bleeding

Treatments

Drug: Heparin and Rivaroxaban

Study type

Interventional

Funder types

Other

Identifiers

NCT04397289
XJTU1AF2017LSK-43

Details and patient eligibility

About

  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.

  5. Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.

  6. ) Heparin group

  7. ) Rivaroxaban group

  8. ) Control group.

Full 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:

  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.

  5. Research subgroup According to the order of the patients, the following groups are entered in turn, and the cycle is repeated.

  6. ) 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.

  7. ) Rivaroxaban group: Rivaroxaban 10mg po qd from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.

  8. ) 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.

  9. 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.

Enrollment

70 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 3 patient groups

Heparin group
Experimental group
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.
Treatment:
Drug: Heparin and Rivaroxaban
Rivaroxaban group
Experimental group
Description:
Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation. PT/INR was kept at 1.25-1.5.
Treatment:
Drug: Heparin and Rivaroxaban
Control group
Sham Comparator group
Description:
No preventive intervention measures.
Treatment:
Drug: Heparin and Rivaroxaban

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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