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:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00336258
First received: June 12, 2006
Last updated: December 13, 2010
Last verified: April 2007
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Beck-Razi N, Rambam medicl center
ClinicalTrials.gov Identifier: NCT00336258     History of Changes
Other Study ID Numbers: BECKCTIL
Study First Received: June 12, 2006
Last Updated: December 13, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014