Contact information
Type
Scientific
Primary contact
Dr B.J. Biemond
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Clinical Chemistry
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5667391
b.j.biemond@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Low dose nadroparin will prevent symptomatic and asymptomatic catheter-related deep vein thrombosis in patients treated with high dose chemotherapy.
Ethics approval
Not provided at time of registration
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Hemato-oncology patients with deep vein thrombosis
Intervention
Subcutaneous (SC) nadroparin 1 dd 2850 E versus subcutaneous placebo 0.3 ml for 21 days
Intervention type
Drug
Phase
Not Specified
Drug names
Nadroparin
Primary outcome measures
Asymptomatic and symptomatic catheter-related deep vein thrombosis proven by ultrasound or venography
Secondary outcome measures
1. Catheter-related infections
2. Bleeding complications
Overall trial start date
10/04/2002
Overall trial end date
01/07/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Current anticoagulant therapy
2. Allergy for contrastmedia
3.Promyelocytic leukemia (AML-M3)
4. Bleeding tendency
5. Renal failure
Recruitment start date
10/04/2002
Recruitment end date
01/07/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Funders
Funder type
University/education
Funder name
Academic Medical Center (AMC)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary