Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450528
Status:
COMPLETED
Last Update Posted:
2007-10-24
First Post:
2007-03-21
Brief Title:
Kinetics of D-Dimers After Abdominal Surgery
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
The Kinetics of D-Dimers After Abdominal Surgery as a Function of the Invasiveness of Surgery
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is to investigate the natural kinetics of D-dimers that occur after abdominal surgery
Detailed Description:
Venous thromboembolism VTE is a potentially fatal disease with an estimated incidence of 01 One third of the VTE occur as pulmonal embolism with a mortality up to 25 White RH Circulation 1072003
Serum d-dimer levels are used as sensitive marker for the diagnosis of VTE Kelly J et al Arch Intern Med 162 2002 Because of its sensitivity the determination of serum D-dimer levels is an accepted method to exclude VTE in the outpatient setting meaning that VTE may be excluded in case of normal D-dimer levels Kelly J Lancet 359 2002 The specificity of the D-dimer testing however is low This is true especially in the postoperative phase The interpretation of elevated D-dimer levels in surgical patients remains elusive
The natural kinetics of D-dimers after surgery is not known The question to what extent D-dimer levels rise after surgery and how long it may take D-dimer levels to return to normal after surgery is not yet determined This information is needed to be able to use D-dimer testing for VTE diagnosis in surgical patients
In this study D-dimer levels are measured in surgical patients immediately before day 0 and repeatedly after surgery D-dimer level measurement will be stopped after D-dimer levels returned to normal
Serum d-dimer levels are used as sensitive marker for the diagnosis of VTE Kelly J et al Arch Intern Med 162 2002 Because of its sensitivity the determination of serum D-dimer levels is an accepted method to exclude VTE in the outpatient setting meaning that VTE may be excluded in case of normal D-dimer levels Kelly J Lancet 359 2002 The specificity of the D-dimer testing however is low This is true especially in the postoperative phase The interpretation of elevated D-dimer levels in surgical patients remains elusive
The natural kinetics of D-dimers after surgery is not known The question to what extent D-dimer levels rise after surgery and how long it may take D-dimer levels to return to normal after surgery is not yet determined This information is needed to be able to use D-dimer testing for VTE diagnosis in surgical patients
In this study D-dimer levels are measured in surgical patients immediately before day 0 and repeatedly after surgery D-dimer level measurement will be stopped after D-dimer levels returned to normal
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