Kinetics of D-Dimers After Abdominal Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00450528
First received: March 21, 2007
Last updated: October 23, 2007
Last verified: October 2007
  Purpose

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


Condition
Natural Kicetics of d-Dimers After Surgery

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Kinetics of D-Dimers After Abdominal Surgery as a Function of the Invasiveness of Surgery

Further study details as provided by University of Zurich:

Estimated Enrollment: 90
Study Start Date: February 2007
Study Completion Date: October 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450528

Locations
Switzerland
Univeryity Hospital, Clinic for Visceral- and Transplantation Surgery
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Daniel Dindo, MD University of Zurich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00450528     History of Changes
Other Study ID Numbers: StV 31-2006
Study First Received: March 21, 2007
Last Updated: October 23, 2007
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by University of Zurich:
D-dimers
surgery
kinetics

ClinicalTrials.gov processed this record on April 17, 2014