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Impact on Morbidity and Mortality of Prophylactic Dosing of Low Molecular Weight Heparin in Child-Pugh B Cirrhotic Patients: a Randomized Controlled Study

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cirrhosis

Intervention: Enoxaparine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Armelle Poujol-Robert, Principal Investigator, Affiliation: Assistance Publique - HĂ´pitaux de Paris

Overall contact:
Armelle Poujol-Robert, Phone: 0033 (0)1 49 28 24 63, Email: armelle.poujol-robert@sat.aphp.fr

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

Clinical Details

Official title: Impact on Morbidity and Mortality of Prophylactic Dosing of Low Molecular Weight Heparin in Child-Pugh B Cirrhotic Patients: a Randomized Controlled Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Morbidity and mortality at 24 months

Secondary outcome:

Mortality liver-related or not at 24 months

Adverse events at 24 months

Liver function and fibrosis at 24 months

Thrombosis at 24 months

Compliance

Survival rate without completion

Portal hypertension parameters

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 decompensation) and death. Life expectancy varies from 12-14 years in patients with compensated cirrhosis, to 2-4 years after decompensation. Cirrhosis is associated with thrombosis of the intrahepatic portal and hepatic venous systems leading to parenchymal extinction (atrophy), liver dysfunction and portal hypertension. Regeneration in the areas without microthrombosis, and inflammation are powerful factors inducing liver cancer. Portal and hepatic venous thrombosis have been shown to participate in remodeling the liver architecture and are associated with a worsening outcome. Thrombosis in cirrhosis is thought to result from a procoagulant state due to an imbalance between pro and anticoagulant factor plasma levels, inflammation in and around blood vessels, and a marked slowing down of venous blood flow. Heparin administration, in animal models of liver fibrosis, decreases extra cellular matrix protein synthesis and fibrous tissue deposition. Recently, a reduction in liver decompensation and mortality has been shown in Child-Pugh B7-C10 cirrhotic patients assigned to receive a low dose of enoxaparin (4000IU/d), a low molecular weight heparin, for 48 weeks, compared to patients receiving no anticoagulation therapy. These results are in line with the hypothesis of a protective role of anticoagulation in liver disease progression and a strong association between thrombosis and liver fibrosis. So the main objective of the study is to compare the effect of a 2-year low dosing of Enoxaparin (4000 IU/day) versus no treatment on morbidity and mortality in patients with Child B7-C10 cirrhosis.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Armelle Poujol-Robert, Phone: 0033 (0)1 49 28 24 63, Email: armelle.poujol-robert@sat.aphp.fr

HĂ´pital Saint Antoine, Paris, France; Recruiting
Armelle Poujol-Robert
Additional Information

Starting date: April 2015
Last updated: April 29, 2015

Page last updated: August 23, 2015

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