Condition category
Circulatory System
Date applied
09/06/2006
Date assigned
09/06/2006
Last edited
09/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes