Efficacy and Safety of Nadroparin Calcium-Warfarin Sequential Anticoagulation in Portal Vein Thrombosis in Cirrhotic Patients: A Randomized Controlled Trial

Clin Transl Gastroenterol. 2020 Sep;11(9):e00228. doi: 10.14309/ctg.0000000000000228.

Abstract

Introduction: Anticoagulation therapy in portal vein thrombosis (PVT) in patients with cirrhosis is still a matter of debate. Therefore, the aim of this work was to evaluate the efficacy and safety of nadroparin calcium-warfarin sequential (NWS) anticoagulation therapy in cirrhotic patients and to find an optimal anticoagulation strategy.

Methods: Consecutive cirrhotic patients with PVT who have not received anticoagulation therapy were randomly divided into the NWS therapy group (1-month nadroparin calcium by subcutaneous injection followed by 5-month warfarin by oral administration) and control group (no anticoagulation therapy). Overall recanalization rate of PVT and risks of bleeding were evaluated at the sixth month.

Results: Among 64 patients, complete or partial recanalization of PVT was observed in 20/32 NSW therapy group patients vs 11/32 control group patients (62.5% vs 34.4%, P = 0.024), with no statistically significant difference in bleeding rate. Child-Pugh score (P = 0.023), D-dimer < 2.00 μg/mL (P = 0.020), and NWS anticoagulation therapy (P = 0.004) were predictors associated with the recanalization. NWS anticoagulation therapy (P = 0.008) was an independent predicting factor of recanalization. In the NWS therapy group, the Child-Pugh score (P = 0.007) and albumin level (P = 0.004) were improved in the sixth month.

Discussion: NWS anticoagulation therapy was effective and safe in PVT patients with cirrhosis and could increase the level of albumin. NWS therapy is safe and easily accepted.

Publication types

  • Clinical Trial, Phase IV
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Anticoagulants / administration & dosage*
  • Anticoagulants / adverse effects
  • Drug Administration Schedule
  • Female
  • Fibrin Fibrinogen Degradation Products / analysis
  • Humans
  • Liver Cirrhosis / blood
  • Liver Cirrhosis / complications*
  • Liver Cirrhosis / diagnosis
  • Male
  • Middle Aged
  • Nadroparin / administration & dosage
  • Nadroparin / adverse effects
  • Portal Vein / diagnostic imaging*
  • Prospective Studies
  • Serum Albumin, Human / analysis
  • Severity of Illness Index
  • Tomography, X-Ray Computed
  • Treatment Outcome
  • Venous Thrombosis / blood
  • Venous Thrombosis / diagnosis
  • Venous Thrombosis / drug therapy*
  • Venous Thrombosis / etiology
  • Warfarin / administration & dosage
  • Warfarin / adverse effects

Substances

  • Anticoagulants
  • Fibrin Fibrinogen Degradation Products
  • Nadroparin
  • fibrin fragment D
  • Warfarin
  • Serum Albumin, Human