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NCT00285038 Clinical Trial

Ultrasound (US)-Doppler for the Diagnosis of Asymptomatic Deep Vein Thrombosis (DVT) in Gynecologic Cancer Patients

Deep Vein Thrombosis Clinical Trial

Official title:
US-Doppler for the Diagnosis of Asymptomatic DVT in Gynecologic Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00285038
Other study ID # NIRACTIL
Secondary ID
Status Completed
Phase Phase 2
First received January 30, 2006
Last updated December 13, 2010
Start date March 2006
Est. completion date December 2010

Study information
Verified date January 2006
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT detected by Doppler ultrasound in a selected group of patients suffering from gynecological malignancies.

Description:

The association between malignancy and venous thromboembolism (VTE) is well known. It has been shown that there is a high prevalence of VTE in gynecological malignancies. Early detection of VTE can identify patients who may benefit from anticoagulant therapy and prevent morbidity and mortality.

NO clear guidelines are available for anticoagulant prophylaxis in a selected group of ambulatory gynecological cancer patients. It has been shown, in other selected groups of patients that Ultrasound Doppler can be used in order to diagnose asymptomatic DVT (deep vein thrombosis).

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Gynecological cancer patients

- Ambulatory performance status of 0-2

- Prior to, or during, chemotherapy and/or radiation

Exclusion Criteria:

- Before or near surgery

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Rambam Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

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