Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT02802605
Status:
UNKNOWN
Last Update Posted:
2016-06-16
First Post:
2016-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients
Sponsor:
Instituto de Investigación Marqués de Valdecilla
Organization:
Study Overview
Official Title:
Randomized and Controlled Trial on the Safety and Efficacy of Bemiparin in the Prevention of Thrombotic Events in Hospitalized Cirrhotic Patients
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEMI-2015
Brief Summary:
Prospectively evaluation of the incidence of thromboembolic events in hospitalized cirrhotic patients. 2. Efficacy and safety of use of bemiparin in preventing peripheral and portal thrombosis. 3. Monitoring antiXa levels.
Detailed Description:
PRIMARY OBJECTIVE: To evaluate the safety of prophylactic anticoagulation Bemiparina (HIBOR®) for the prevention of peripheral and portal vein thrombosis in cirrhotic patients with prolonged hospitalization.
Secondary objectives are the following:
1. To evaluate the incidence of thrombotic events in hospitalized cirrhotic patients.
2. To evaluate the efficacy of low molecular weight heparin (HIBOR 3.500UI) in preventing thrombotic events in hospitalized cirrhotic patients.
3. To identify risk factors for development of portal vein thrombosis and deep vein thrombosis in hospitalized patients.
4. Evaluate the morbidity and mortality associated with thromboembolic events.
5. Evaluate prophylactic anticoagulation levels by determining antiXa and antithrombin III.
6. To study the expression profile and functionality of Toll-like receptors as factors intimately involved in the inflammatory response, as well as the variability of different serum markers associated with proinflammatory state: I-FABP / IL6-IL8 / NO, endothelin and LPS-binding protein.
7. Evaluate the effect on liver fibrosis (by Fibroscan®) and serum TGF
8. Evolution of hepatocellular function estimated by the scores of Child-Pugh and MELD.
Secondary objectives are the following:
1. To evaluate the incidence of thrombotic events in hospitalized cirrhotic patients.
2. To evaluate the efficacy of low molecular weight heparin (HIBOR 3.500UI) in preventing thrombotic events in hospitalized cirrhotic patients.
3. To identify risk factors for development of portal vein thrombosis and deep vein thrombosis in hospitalized patients.
4. Evaluate the morbidity and mortality associated with thromboembolic events.
5. Evaluate prophylactic anticoagulation levels by determining antiXa and antithrombin III.
6. To study the expression profile and functionality of Toll-like receptors as factors intimately involved in the inflammatory response, as well as the variability of different serum markers associated with proinflammatory state: I-FABP / IL6-IL8 / NO, endothelin and LPS-binding protein.
7. Evaluate the effect on liver fibrosis (by Fibroscan®) and serum TGF
8. Evolution of hepatocellular function estimated by the scores of Child-Pugh and MELD.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: