Status:
SUSPENDED
Impact on Morbidity and Mortality of Prophylactic Dosing of Low Molecular Heparin in Child-Pugh B Cirrhotic Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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
Detailed Description
Cirrhosis is the end-stage of all chronic liver diseases. Cirrhosis is a critical step in the natural history of liver disease, as it is associated with the occurrence of complications (so-called deco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 27 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02271295
Start Date
July 27 2015
End Date
July 2 2019
Last Update
February 27 2018
Active Locations (1)
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1
Hôpital Saint Antoine
Paris, France