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ISRCTN
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ISRCTN29686154
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ClinicalTrials.gov identifier
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Public title
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Prevention of catheter-related deep vein thrombosis with nadroparin in hemato-oncology patients treated with high dose chemotherapy
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Low dose nadroparin will prevent symptomatic and asymptomatic catheter-related deep vein thrombosis in patients treated with high dose chemotherapy.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomized controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Hemato-oncology patients with deep vein thrombosis
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Participants - inclusion criteria
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1. Central venous catheter
2. Indication for high dose chemotherapy (acute myeloid leukaemia [AML], acute lymphoblastic leukaemia [ALL], myelodysplasia-refractory anemia with excess of blasts in transformation [MDS-RAEB], multiple mye!oma [MM])
3. Informed consent
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Participants - exclusion criteria
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1. Current anticoagulant therapy
2. Allergy for contrastmedia
3.Promyelocytic leukemia (AML-M3)
4. Bleeding tendency
5. Renal failure
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Anticipated start date
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10/04/2002
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Anticipated end date
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01/07/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100
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Interventions
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Subcutaneous (SC) nadroparin 1 dd 2850 E versus subcutaneous placebo 0.3 ml for 21 days
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Primary outcome measure(s)
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Asymptomatic and symptomatic catheter-related deep vein thrombosis proven by ultrasound or venography
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Secondary outcome measure(s)
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1. Catheter-related infections
2. Bleeding complications
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Sources of funding
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Academic Medical Center (AMC)
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Trial website
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Publications
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Contact name
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Dr
B.J.
Biemond
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Address
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Academic Medical Center (AMC)
Department of Clinical Chemistry
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Tel
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+31 (0)20 5667391
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Email
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b.j.biemond@amc.uva.nl
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Sponsor
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Academic Medical Center (AMC) (The Netherlands)
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Address
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P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Date applied
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09/06/2006
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Last edited
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09/06/2006
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Date ISRCTN assigned
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09/06/2006
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