Ignite Creation Date:
2024-05-06 @ 1:32 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04055389
Status:
WITHDRAWN
Last Update Posted:
2022-03-10
First Post:
2019-08-07
Brief Title:
Preventing de Novo Portal Vein Thrombosis With Antithrombin-III in Patients With Cirrhosis
Sponsor:
Jonathan Stine
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Preventing de Novo Portal Vein Thrombosis With Antithrombin-III in Patients With Cirrhosis A Randomized Double-blinded Placebo - Controlled Trial PiVoT-AC Trial
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Challenges with recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PiVoT
Brief Summary:
To prevent portal vein thrombosis PVT in patients with cirrhosis at risk for PVT by pharmacologic prophylaxis with intravenous antithrombin AT-III
Detailed Description:
PVT is a common complication in patients with cirrhosis affecting 10 to 25 of patients PVT is a potentially life-threatening occurrence complicating transplant candidacy and reducing five-year survival In addition to the mortality risk posed by PVT microthrombi within the liver have been linked to decompensation due to the phenomenon of parenchymal extinction Because of the developing understanding of a baseline hypercoagulable state in many cirrhosis patients recent studies have demonstrated the benefit of prophylactic anticoagulation with enoxaparin in patients with cirrhosis to prevent PVT In addition to the benefit in reducing PVT prophylactic anticoagulation was also found to reduce liver decompensation and improve overall survival
Risk factors for PVT are well described The strongest independent risk factor for PVT is portal vein velocity For each 1 cms decrease in portal vein velocity PVT risk increases 16 Portal vein velocity 15cmsec is the best-established cutoff for predicting the development of de novo PVT over the ensuing twelve months
In addition patients with cirrhosis and venous thromboembolism PVT deep vein thrombosis pulmonary embolus have abnormally low levels of AT-III A recent report by the NPB-06 study group suggest that administering intravenous AT-III at dosage of 1500 unitsday for five consecutive days in patients with cirrhosis and AT-III 70 serum level is a safe and effective treatment for PVT with promising short-term partial and complete resolution of PVT Despite this the role of AT repletion in preventing PVT remains unknown
Risk factors for PVT are well described The strongest independent risk factor for PVT is portal vein velocity For each 1 cms decrease in portal vein velocity PVT risk increases 16 Portal vein velocity 15cmsec is the best-established cutoff for predicting the development of de novo PVT over the ensuing twelve months
In addition patients with cirrhosis and venous thromboembolism PVT deep vein thrombosis pulmonary embolus have abnormally low levels of AT-III A recent report by the NPB-06 study group suggest that administering intravenous AT-III at dosage of 1500 unitsday for five consecutive days in patients with cirrhosis and AT-III 70 serum level is a safe and effective treatment for PVT with promising short-term partial and complete resolution of PVT Despite this the role of AT repletion in preventing PVT remains unknown
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None