We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

US-Doppler and Procoagulant Microparticles for the Diagnosis of Asymptomatic DVT in Advanced Cancer Patients With Poor Performance Status

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00336258
First Posted: June 13, 2006
Last Update Posted: December 14, 2010
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:
Rambam Health Care Campus
  Purpose

The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT detected by US-Doppler and procoagulant microparticles in a selected group of cancer patients suffering from an advanced stage of the disease.

An attempt will be made to determine whether there is a correlation between this prevalence and various clinical and laboratory parameters.


Condition
Deep Vein Thrombosis Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: US-Doppler and Procoagulant Microparticles for the Diagnosis of Asymptomatic DVT in Advanced Cancer Patients With Poor Performance Status

Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment: 100
Study Start Date: June 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

The association between malignancy and venous thromboembolism(VTE) is well known. VTE is one of the most common complications seen in cancer patients Early detection of VTE can identify patients who may benefit from anticoagulant therapy and prevent morbidity and mortality.

There are recommendations for hospitalized cancer patients who are bedridden with an acute medical illness to receive prophylaxis, but in practice this is not clear cut.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). Hematological coagulation tests, including procoagulant microparticles will be performed for the evaluation of coagulation profile, in order to evaluate the possible correlation between the prevalence of asymptomatic DVT and these laboratory parameters.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with an advanced stage of the disease, hospitalized in the oncology department.
Criteria

Inclusion Criteria:

  • Cancer patients with an advanced stage of the disease, hospitalized in the oncology department.
  • WHO performance status of 3( i.e. spends more than half his/her time in bed or seated) - or 4 ( i.e. completely confined to bed or to chair) : for at least a week; according to the treating physician, the poor performance status results from advanced malignancy.
  • Patient is asymptomatic for lower extremity DVT according to the treating physician

Exclusion Criteria:

  • major surgery during more than a month, from the time of investigation
  • anticoagulant therapy for more than one month, from the time of investigation
  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): NCT00336258


Locations
Israel
Rambam medical center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Nira Beck-Razi Ministry of Health, Israel
  More Information

Responsible Party: Dr Beck-Razi N, Rambam medicl center
ClinicalTrials.gov Identifier: NCT00336258     History of Changes
Other Study ID Numbers: BECKCTIL
First Submitted: June 12, 2006
First Posted: June 13, 2006
Last Update Posted: December 14, 2010
Last Verified: April 2007

Keywords provided by Rambam Health Care Campus:
Deep Vein Thrombosis
Cancer
US- Doppler
Procoagulant Microparticles
Asymptomatic

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases