Kinetics of D-Dimers After Abdominal Surgery

NCT ID: NCT00450528

Last Updated: 2007-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Natural Kicetics of d-Dimers After Surgery

Keywords

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D-dimers surgery kinetics

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Principal Investigators

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Daniel Dindo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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Univeryity Hospital, Clinic for Visceral- and Transplantation Surgery

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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StV 31-2006

Identifier Type: -

Identifier Source: org_study_id