Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00199602
|Contact: Nicole TUBIANA-MATHIEU, MD||+33(0) 555 056 email@example.com|
|Limoges, France, 87000|
|Contact: Nicole TUBIANA-MATHIEU, MD|
|Principal Investigator: Nicole TUBIANA-MATHIEU, MD|
|Principal Investigator:||Nicole TUBIANA-MATHIEU, MD||University Hospital, Limoges|