Trial about the prevention of thrombosis in hospitalized cirrhotic patients

Phase 1

• Conditions: Prevention of thrombosis in cirrhotic patients; MedDRA version: 18.1 Level: HLGT Classification code 10014523 Term: Embolism and thrombosis System Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-003866-96-ES
• Lead Sponsor: ANGELA PUENTE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-03
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 225

Inclusion Criteria

Applicants must meet all the following: 1) Liver cirrhosis of any etiology diagnosed
by biopsy or after clinical, laboratory and ultrasound criteria; 2) Admission to
hospital more than 3 days of their liver decompensation (ascites, encephalopathy,
upper gastrointestinal bleeding or low controlled, spontaneous bacterial peritonitis)
3) signed written consent.4) women in childbearing age with use of effective
contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

One or more of the following: 1) Age <18 and> 80 years; 2) contraindication to
heparin treatment of low molecular weight, 3) uncontrolled bleeding 4) Any
comorbidity involving a therapeutic limitation and / or a life expectancy <6 months;
5) concomitant antiplatelet therapy (aspirin, clopidogrel, ticlopidine, dipyridamole,
sulfinpyrazone, dextran 40, or other anticoagulants 6) and continued concomitant
NSAIDs, salicylates, corticosteroids; 7) existence of clinically significant esophageal
varices / severe gastropathy of portal hypertension without their having been
previously treated with primary / secondary prophylaxis (endoscopic variceal ligation
/ non-cardioselective beta-blockers); 8) refusal to participate in the study or to sign
the informed consent; 9) Pregnancy and lactation; 10) HIV infection; 11) severe
thrombocytopenia <20,000 platelets / dl, 12) Failure to severe with lower clearance
30ml / min Renal 13) portal vein thrombosis or peripheral thrombosis diagnosed on
admission, 14) Presence of previously known procoagulant factor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified