Impact on Morbidity and Mortality of Prophylactic Dosing of Low Molecular Heparin in Child-Pugh B Cirrhotic Patients

• Status: Suspended
• Trial end date: 2019-07-02
• Target enrollment: 0
• Participant gender: All

Summary

Thrombosis occurring in the small intrahepatic, as well as in the large vessels is involved in the progression of cirrhosis. Anticoagulation could reduce morbidity and mortality in cirrhotic patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight

Criteria

Inclusion Criteria:

• Age ≥18 and ≤75 years old

• A diagnosis of cirrhosis based on liver biopsy or on the combination of clinical, laboratory and imaging criteria

• Compensated Child-Pugh B7-C10

• Any of the following causal factors : past but controlled excessive alcohol intake (<30g/d for men and <20g/d for women), HCV infection without viral replication, HBV infection without viral replication on therapy, metabolic syndrome, biliary cirrhosis, auto-immune cirrhosis, hemochromatosis, cryptogenetic cirrhosis

Exclusion Criteria:

• Ascites, portal hypertensive bleeding or encephalopathy within the last 3 months prior to enrolment

• Hepatocellular carcinoma non considered in remission

• Budd Chiari syndrome non considered in remission

• Liver transplantation

• F2 or F3 varices without treatment in accordance with recommended guidelines (B-blockers, ligation or both)

• Portal vein thrombosis

• Transjugular intrahepatic portosystemic shunt

• Known extra-hepatic malignancies

• PT<35%

• Platelet count<50,000/mm3

• Haemoglobin level < 9g/dl

• Serum Albumin < 20g/L

• A bone mineral density T score of less than -4.0 at the lumbar spine or total hip

• Known HIV infection

• Ongoing anticoagulation or antiaggregation

• Renal insufficiency defined by creatinine clearance<60ml/mn

• Conditions at risk for spontaneous bleeding (except for portal hypertension) or hemostatic abnormalities not related to cirrhosis

• Pregnancy or breast-feeding