Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-04 @ 5:40 PM
Study NCT ID:
NCT00981903
Status:
TERMINATED
Last Update Posted:
2017-07-06
First Post:
2009-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Tinzaparin will no longer be available in the United States
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study the investigators will determine the safety and effectiveness of Tinzaparin in preventing blood clots for up to 12 months of treatment.
Detailed Description:
The purpose of this study is to use long-term administration of a low molecular weight heparin (tinzaparin) for primary treatment and secondary prophylaxis of venous thromboembolism in patients with cancer. We will determine the efficacy (recurrent VTE) and safety (major hemorrhage) of this approach. Secondarily, we will analyze the outcome of patients in terms of survival and response to therapy versus matched controls. We will also determine baseline levels of markers of hemostasis, fibrinolysis, and angiogenesis and will follow changes with treatment as well as correlate levels of these plasma markers with outcomes, including recurrent venous thromboembolism, major hemorrhage,and survival.
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?: