Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lack of drug prophylaxis | No Intervention | ||
| HBPM 2500 UI anti Xa in one subcutaneous injection per day | Experimental |
| |
| warfarine 1mg daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| warfarine - low molecular heparin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 : | Day90 | |
| Low molecular weight Heparin (LMWH) 2500 U anti-XA/day or Warfarine 1 mg/day during the first line of chemotherapy | Day90 |
| Measure | Description | Time Frame |
|---|---|---|
| - Detection of asymptomatic thrombosis related to implantable device estimated by a systematic echo-doppler. - | Day90 | |
| - Frequency of other symptomatic venous thromboembolic events between 3 groups. | J0, J1, J21, J42, J63 and J90 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicole TUBIANA-MATHIEU, MD | University Hospital, Limoges | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncologie Médicale | Limoges | 87000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23636449 | Result | Lavau-Denes S, Lacroix P, Maubon A, Preux PM, Genet D, Venat-Bouvet L, Labourey JL, Martin J, Slaouti P, Tubiana-Mathieu N. Prophylaxis of catheter-related deep vein thrombosis in cancer patients with low-dose warfarin, low molecular weight heparin, or control: a randomized, controlled, phase III study. Cancer Chemother Pharmacol. 2013 Jul;72(1):65-73. doi: 10.1007/s00280-013-2169-y. Epub 2013 May 1. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparison of thrombosis prophylaxis by LMWH with warfarin at low dose | Day90 |
| -Costs in the 3 strategies | J90 |
| - Tumoral response to chemotherapy in the 3 groups. | Day90 |
| - Overall survival in each group. | Day90 |