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Kinetics of D-Dimers After Abdominal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00450528
First Posted: March 22, 2007
Last Update Posted: October 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Zurich
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00450528     History of Changes
Other Study ID Numbers: StV 31-2006
First Submitted: March 21, 2007
First Posted: March 22, 2007
Last Update Posted: October 24, 2007
Last Verified: October 2007

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

Additional relevant MeSH terms:
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants