US-Doppler and Procoagulant Microparticles for the Diagnosis of Asymptomatic DVT in Advanced Cancer Patients With Poor Performance Status
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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 |
| 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) |
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 |
patients with an advanced stage of the disease, hospitalized in the oncology department.
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 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 Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013