Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043277
Status:
COMPLETED
Last Update Posted:
2006-02-01
First Post:
2002-08-07
Brief Title:
Study Of Angiomax In Infants Under Six Months With Thrombosis
Sponsor:
The Medicines Company
Organization:
The Medicines Company
Study Overview
Official Title:
Pilot Dose Finding And Efficacy Study Of Angiomax Bivalirudin As Primary Anticoagulation In Infants Under Six Months With Thrombosis
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goals of this study are
1 To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis
2 To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time ACT or activated partial thromboplastin time aPTT in Infants Under Six Months with arterial or venous thrombosis
3 To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin UH or low molecular weight heparin LMWH
1 To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis
2 To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time ACT or activated partial thromboplastin time aPTT in Infants Under Six Months with arterial or venous thrombosis
3 To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin UH or low molecular weight heparin LMWH
Detailed Description:
The goals of this study are
1 To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis
2 To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time ACT or activated partial thromboplastin time aPTT in Infants Under Six Months with arterial or venous thrombosis
3 To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin UH or low molecular weight heparin LMWH
1 To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis
2 To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time ACT or activated partial thromboplastin time aPTT in Infants Under Six Months with arterial or venous thrombosis
3 To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin UH or low molecular weight heparin LMWH
Study Oversight
Has Oversight DMC:
None
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?:
None