Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00199602|
Recruitment Status : Unknown
Verified December 2008 by University Hospital, Limoges.
Recruitment status was: Recruiting
First Posted : September 20, 2005
Last Update Posted : December 31, 2008
This is a Phase III open-labed, multicenter, prospective, randomised study, and comparative 3-arms of 140 patients (i.e. 420 total patients).
Study period (date of first inclusion/last inclusion): 3 years Treatment period : 3 months
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: warfarine - low molecular heparin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||420 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study|
|Study Start Date :||August 1999|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
- Evaluation of the prevalence of symptomatic or asymptomatic deep venous thrombosis in cancer patients with implantable device for central venous access with or without prophylaxis :
- Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy
- - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. -
- - Frequency of other symptomatic venous thromboembolic events between 3 groups.
- Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose
- -Costs in the 3 strategies
- - Tumoral response to chemotherapy in the 3 groups.
- - Overall survival in each group.
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): NCT00199602
|Contact: Nicole TUBIANA-MATHIEU, MD||+33(0) 555 056 firstname.lastname@example.org|
|Limoges, France, 87000|
|Contact: Nicole TUBIANA-MATHIEU, MD|
|Principal Investigator: Nicole TUBIANA-MATHIEU, MD|
|Principal Investigator:||Nicole TUBIANA-MATHIEU, MD||University Hospital, Limoges|