Prevention of catheter-related deep vein thrombosis with nadroparin in hemato-oncology patients treated with high-dose chemotherapy

ISRCTN	ISRCTN29686154
DOI	https://doi.org/10.1186/ISRCTN29686154
Secondary identifying numbers	NL611, NTR669

Submission date: 09/06/2006
Registration date: 09/06/2006
Last edited: 08/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr B.J. Biemond
Scientific

Academic Medical Center (AMC)
Department of Clinical Chemistry
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5667391
Email	b.j.biemond@amc.uva.nl

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Prevention of catheter-related deep vein thrombosis with nadroparin in hemato-oncology patients treated with high-dose chemotherapy
Study objectives	Low dose nadroparin will prevent symptomatic and asymptomatic catheter-related deep vein thrombosis in patients treated with high dose chemotherapy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Nadroparin
Primary outcome measure	Asymptomatic and symptomatic catheter-related deep vein thrombosis proven by ultrasound or venography
Secondary outcome measures	1. Catheter-related infections 2. Bleeding complications
Overall study start date	10/04/2002
Completion date	01/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	100
Total final enrolment	113
Key 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
Key exclusion criteria	1. Current anticoagulant therapy 2. Allergy for contrastmedia 3.Promyelocytic leukemia (AML-M3) 4. Bleeding tendency 5. Renal failure
Date of first enrolment	10/04/2002
Date of final enrolment	01/07/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
University/education

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

"ROR"	https://ror.org/03t4gr691

Funders

Funder type

University/education

Academic Medical Center (AMC)
Private sector organisation / Universities (academic only)

Alternative name(s): Academic Medical Center, AMC
Location: Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2007	08/01/2021	Yes	No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.