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 |
| Protocol serial number | NL611, NTR669 |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Funder | Academic Medical Center (AMC) |
- 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
Scientific
Academic Medical Center (AMC)
Department of Clinical Chemistry
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5667391 |
|---|---|
| b.j.biemond@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nadroparin |
| Primary outcome measure(s) |
Asymptomatic and symptomatic catheter-related deep vein thrombosis proven by ultrasound or venography |
| Key secondary outcome measure(s) |
1. Catheter-related infections |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
