Kinetics of D-Dimers After Abdominal Surgery

Natural Kicetics of d-Dimers After Surgery Clinical Trial

Official title:

The Kinetics of D-Dimers After Abdominal Surgery as a Function of the Invasiveness of Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450528
• Other study ID #: StV 31-2006
• Status: Completed
• Phase: N/A
• First received: March 21, 2007
• Last updated: October 23, 2007
• Start date: February 2007
• Est. completion date: October 2007

Study information

• Verified date: October 2007
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the natural kinetics of D-dimers that occur after abdominal surgery.

Description:

Venous thromboembolism (VTE) is a potentially fatal disease with an estimated incidence of 0.1%. One third of the VTE occur as pulmonal embolism with a mortality up to 25% (White RH. Circulation 107:2003)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients undergoing elective surgery

Exclusion Criteria:

• age < 18 years

• patients not speaking german

• patients involved in another study

• pregnancy

• concommitant inflammatory disease

• patients with oral anticoagulation

• patients having received fresh frozen plasma

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Natural Kicetics of d-Dimers After Surgery

Locations

Country	Name	City	State
Switzerland	Univeryity Hospital, Clinic for Visceral- and Transplantation Surgery	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland,