Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346879
Status:
WITHDRAWN
Last Update Posted:
2016-02-23
First Post:
2006-06-28
Brief Title:
Study to Determine Effective Dosing of Fondaparinux in Obese Persons
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Thromboprophylaxis in the Morbidly Obese With Weight Based Dosing of Fondaparinux A Pharmacodynamic Study
Status:
WITHDRAWN
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding withdrawn study closed due to lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective open-label study comparing two dosing regimens of fondaparinux which is used to prevent deep vein thrombosis in morbidly obese volunteers
Detailed Description:
The incidence of obesity is growing at an alarming pace and has reached epidemic proportions Subjects who are more than 100 pounds over their ideal body weight are classified as being morbidly obese and are considered to carry a high risk for multiple chronic medical conditions that impact quality of life and shorten life span As a result of obesity these individuals are also at a higher risk for developing life-threatening blood clots Such risk is further elevated with exposure of obese subjects to the stress of surgery In fact the most common cause of death after major surgery in morbidly obese subjects is the migration of blood clots to the lung and heart With the current rise in popularity of weight loss surgery it has become imperative that we identify a medication that is safe and effective in preventing the formation of blood clots Fondaparinux has the potential for being an effective anti-clotting drug It is superior to other similar drugs because it is completely utilized by the body and has a more predictable action The problem however is that the recommended doses for fondaparinux were obtained after studies on lean individuals This is a fixed dose that is administered universally regardless of the size of the subject Presently we have no information on what the recommended doses should be for morbidly obese subjects who are in the most need for effective anti-clotting medication This study will attempt to determine whether a fixed dose or a weight-related dose is appropriate for morbidly obese subjects and also investigate the safety of administering weight-based dosing to these individuals
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